REaCT
REthinking Clinical Trials

Studies

REaCT studies typically focus on comparing commonly-used treatments, rather than testing new treatments. They are designed so that a wide range of people with cancer can easily participate without the need for extra tests, hospital visits or lengthy consent forms. Data are typically gathered in real-time from electronic medical records and through quality of life surveys. By simplifying the process, REaCT trials can involve more patients and produce results that more accurately reflect the patient population. REaCT trials also have economic evaluation embedded to ensure evaluation of value to both patients and the health care system.

REaCT methodology publications:

Methodology for Comparing Standard-of-Care Interventions in Patients With Cancer. Hilton et al, 2016. PMID: 27650842
Creating a pragmatic trials program for breast cancer patients: Rethinking Clinical Trials (REaCT). Basulaiman et al, 2019. PMID: 31127468

Program publications:

Integrating Systematic Reviews into Supportive Care Trial Design: The Rethinking Clinical Trials (REaCT) Program. Ashamsan et al, 2022. PMID: 36547164
A Canadian-Led Pragmatic Trials Program: Strategies for Integrating Knowledge Users into Trial Design. Saunders et al, 2021. PMID: 34677255

How do I participate?

Patients who are interested in learning more about a REaCT trial should speak with their primary care physician.

All REaCT studies are registered on a public registry (www.ClinicalTrials.gov) which lists all study details including criteria for participation, treatments being compared, current status of the study, and contact information for the principal investigator.

Active and Recruiting Patients Closed and Completed Studies

REaCT-TEMPO	Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance. Principal Investigator(s): Dr. Marie-France Savard
ClinicalTrials.gov: NCT05754528
This study is for patients with early stage breast cancer that are starting endocrine therapy. This is a pragmatic open-label, randomized clinical trial to establish if a dose-frequency escalation strategy of administering endocrine therapy will improve side effects and benefits in early stage breast cancer patients. Different strategies to help reduce side effects have been studied but none have clearly been shown to help patients take their hormonal therapy as prescribed by their physician. The aim of this study is to determine if taking hormone therapy every other day for one month and then daily (“dose-frequency escalation”) as opposed to daily from the start will help improve the tolerability and adherence to endocrine therapy. Many physicians start patients on lower doses of tablets at the start of treatment and there is supporting evidence from other trials showing this is an effective strategy with no added risk.
Sites: The Ottawa Hospital Thunder Bay
Tags: Early stage Breast Cancer

REaCT-HER TIME	Evaluating 6-months of herceptin in patients with HER2 positive early-stage breast cancer Principal Investigator(s): Dr. Sharon McGee
ClinicalTrials.gov: NCT04928261
Patients with HER2 positive breast cancer that were treated with chemotherapy and HER2 targeted therapy (such as Herceptin ®) before breast surgery, with no evidence of any remaining cancer at the time of surgery, are considered to have a low risk cancer. This single arm study will evaluate patient follow up data, cardiac monitoring and quality of life to determine if a shorter course of HER2 targeted therapy is acceptable in this low risk patient population.
Sites: The Ottawa Hospital
Tags: Early stage Breast Cancer
Publications: Survey: Shorter durations of anti-HER2 therapy for patients with early-stage, HER2-positive breast cancer: the physician perspective. Bradbury et al, 2023. PMID:38132397

REaCT-70	Risks and benefits of hormonal therapy in patients with low risk breast cancer who are 70 years of age and older. Principal Investigator(s): Dr. Marie-France Savard
ClinicalTrials.gov: NCT04921137
This study is for patients with low risk breast cancer who are 70 years of age or older. The standard of care for this population would be breast-conserving surgery followed by radiotherapy, or mastectomy, and hormonal therapy. Hormonal therapy is a pill to take every day for 5 years. The side effects of hormonal therapy are significant and include: fatigue, hot flashes, joint pain/body aches, bone loss or osteoporosis, bone fracture, blood clots, cardiovascular disease, cognitive impairment and endometrial cancer. For older patients, it is not clear if the benefits of hormonal therapy outweigh the risks because older patients have an increased number of other diseases or health conditions which makes them more at risk to side effects that affect their quality of life and lifestyle. The goal of this proposed study is to randomize patients to radiotherapy plus hormonal therapy vs radiotherapy alone and evaluate the risks and benefits of hormonal therapy in this older patient population.
Sites: Allan Blair Cancer Centre (Regina) Grand River Hospital (Kitchener Waterloo) London Health Sciences Centre Markham Stouffville Hospital Saskatoon Cancer Centre The Ottawa Hospital Thunder Bay Health Research Institute
Tags: Early stage Breast Cancer
Publications: Systematic Review: De-escalating adjuvant therapies in older patients with lower risk estrogen receptor-positive breast cancer treated with breast-conserving surgery: A systematic review and meta-analysis. Savard et al. PMID: 34242928 Surveys: Management strategies for older patients with low risk early stage breast cancer: a physician survey. Alzahrani et al. 2021. PMID: 35049675 Experiences and Perceptions of Older Adults with Lower-risk Hormone Receptor-positive Breast Cancer about Adjuvant Radiotherapy and Endocrine Therapy: A Patient Survey. Savard et al. PMID: 34940075

REaCT-NSQIP	Oral antibiotics (pre-treatment vs no treatment) in colorectal surgery Principal Principal Investigator(s): Dr. Rebecca Auer
ClinicalTrials.gov: NCT03663504
The divergence of clinical practice guidelines, in addition to observation from the large North American retrospective studies, suggest that surgeons and centers have not established a standard of care for the preoperative preparation of the bowel prior to colorectal surgery. Multiple trials have demonstrated that the use of mechanical bowel preparation (MBP) has been associated with no reduction and possibly an increase in surgical infections but that MBP plus oral antibiotics are superior to MBP alone.  In this study, we hypothesize that it is the oral antibiotics, and not the MBP, that is responsible for the reduction in postoperative infectious surgical complications in patients undergoing elective colorectal resections. Funded by a TOHAMO Innovation grant.
Sites: Hopital Montfort Mount Sinai Cancer Centre Queensway Carleton Hospital The Ottawa Hospital Toronto Western (UHN)
Tags: Colon cancer Surgery
Publications: Study Protocol: Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol. Apte et al, 2020. PMID: 32647023

REaCT-HOLD BMA	De-escalating BMA treatment after two years vs continuing Principal Investigator(s): Dr. Terry Ng
ClinicalTrials.gov: NCT04549207
While informal surveys of oncologists and patients have suggested that they would not want to discontinue BMA therapy entirely after 2 years of treatment, they are interested in de-escalating to treatment every 24 weeks, and this de-escalated interval is supported by data from the osteoporosis population. Indeed, clinical experience shows that many oncologists already further de-escalate and sometime stop prescriping BMAs in patients who have been on these agents for several years. This study is the first pragmatic, multicentre, open-label, randomized clinical trial to evaluate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and metastatic castration-resistant prostate cancer. Funded by a TOHAMO Innovation grant.
Sites: London Health Sciences Centre Southlake Regional Health Centre (Newmarket) The Ottawa Hospital William Osler Health Centre (Brampton)
Tags: Castration-resistant prostate cancer Metastatic breast cancer
Publications: Systematic Review: Long-term impact of bone-modifying agents for the treatment of bone metastases: a systematic review. Ng et al, 2020. PMID: 32535678 Survey: Real-world practice patterns and attitudes towards de-escalation of bone-modifying agents in patients with bone metastases from breast and prostate cancer: A physician survey. AlZharani et al, 2020. PMID: 33294318 Perceptions around bone-modifying agent use in patients with bone metastases from breast and castration resistant prostate cancer: A patient survey. Alzahrani et al. 2021. PMID: 34023950

REaCT-Wellness	A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer Principal Investigator(s): Dr. Mark Clemons
ClinicalTrials.gov: NCT05365230
After breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. Multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. The frequency of follow-up varies between and within different institutions. To date, no de-escalation strategy has appropriately evaluated patient reported outcomes such as quality of life or perception of care. There has been a growing body of evidence that de-intensification of follow-up is safe, effective and reduces costs for both patients and the health care system. Therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.
Sites: The Ottawa Hospital
Tags: Early stage Breast Cancer
Publications: Regularly scheduled physical examinations and the detection of breast cancer recurrences. Beltran-Bless et al, 2023. PMID: 36922304 Surveys: The COVID-19 pandemic and its effects on follow-up of patients with early breast cancer: a patient survey. Beltran-Bless et al, 2023 (in press). Evolving strategies for the routine follow-up of patients with early breast cancer and the impact of COVID-19: a survey of healthcare providers. Beltran-Bless et al, 2023 (under review).

REaCT-5G	Type of G-CSF treatment (PEF vs FIL) during chemotherapy, impact on bone pain Principal Investigator(s): Dr. Terry Ng
ClinicalTrials.gov: NCT04781959
Patients with early stage breast cancer who are being treated with chemotherapy also receive an injectable medication called granulocyte colony stimulating factor (G-CSF). G-CSF works by stimulating bone marrow to produce more immune cells to fight infection. Although G-CSF injections are effective at preventing infections, one of the most common side effects is bone pain. This multicenter, randomized clinical trial will compare bone pain experienced by patients after receiving either PEG or 5 days of FIL with adjuvant chemotherapy. This will be the first study to prospectively evaluate the patient-reported outcome of bone pain in this treatment comparison.
Sites: The Ottawa Hospital
Tags: Early stage Breast Cancer

REaCT-Hot Flashes Project	Project for patient survey for patients with early stage breast cancer, that have experienced hot flashes. Principal Investigator(s): Dr. Sharon McGee
ClinicalTrials.gov: not applicable
REaCT-Hot Flashes is a study investigating treatment-related, vasomotor symptoms, in patients with early-stage breast cancer. These symptoms include hot flashes, and sweats, and can occur due to the impacts of chemotherapy, and/or endocrine therapy, on estrogen levels in the body. These symptoms can negatively impact patient quality of life and impair treatment compliance. The goal of this study is to increase our understanding of vasomotor symptoms to help design randomized clinical trials to improve their management.
Sites: London Health Sciences Centre The Ottawa Hospital
Tags: Early stage Breast Cancer Survey
Survey: Developing Patient-Centered Strategies to Optimize the Management of Vasomotor Symptoms in Breast Cancer Patients: A Survey of Health Care Providers. Cole et al, 2021. PMID: 34159473 Using machine learning to predict individual patient toxicities from cancer treatments. Cole et al, 2022. PMID: 35614153

REaCT-CHRONO	Impact of time of day (morning vs evening) when taking hormonal therapy Principal Investigator(s): Dr. Marie-France Savard (TOH) and Dr. Mohammed Ibrahim (Thunder Bay)
ClinicalTrials.gov: NCT04864405
Endocrine (hormonal) therapy is an established treatment for patients with hormone receptor-positive breast cancer. Endocrine therapy can cause significant side effects with deterioration in quality of life. The side effects from endocrine therapy are well recognised and can lead to patients taking their treatment inconsistently or stopping treatment altogether. Chronotherapy is the study of taking medication in coordination with the patient's natural circadian rhythm to try to reduce side effects. There is uncertainty about the best time of day (morning versus evening) at which to take the hormone therapy pills. This study will allow us to determine the best time of day (morning vs evening) to take endocrine therapy. This type of study has not been done before and will help us to better advise future patients.
Sites: The Ottawa Hospital Thunder Bay Health Research Institute
Tags: Breast cancer
Publications: Systematic Review: Does the Time of Day at Which Endocrine Therapy Is Taken Affect Breast Cancer Patient Outcomes? Beltran-Bless et al. 2021. PMID: 34287262

REaCT-Algorithm	Observing Oncotype DX ordering behaviour at 6 Ontario sites Principal Investigator(s): Dr. Arif Awan
ClinicalTrials.gov: NCT04131933
Only some patients with early-stage hormone receptor positive breast cancer benefit from chemotherapy which can have some significant side effects. Patients and clinicians rely on the classic factors such as patient’s tumor size, grade, age in a publicly available tool called PREDICT 2.1 as well as newer and expensive genomic tests looking at patient’s cancer genetic make-up to decide whether there’s a substantial benefit of chemotherapy. In this trial we are assessing how clinicians use PREDICT 2.1 and the genomic tests in their practice with patients to guide decision-making around adjuvant chemotherapy. Funded by a OICR Health Services Research grant.
Sites: Cancer Centre of Southeastern Ontario (Kingston) Grand River Hospital (Kitchener Waterloo) Markham Stouffville Hospital The Ottawa Hospital Thunder Bay Regional Health Sciences Centre Windsor Regional Hospital
Tags: Early stage Breast Cancer
Publications: Does preemptive availability of PREDICT 2.1 results change ordering practices for Oncotype DX? A multi-center prospective cohort study. Awan et al, 2023. Under review Previous Trial and Economic Analysis: Does integration of Magee equations into routine clinical practice affect whether oncologists order the Oncotype DX test? A prospective randomized trial. Robertson et all, 2019. PMID: 30672056 Cost analysis of using Magee scores as a surrogate of Oncotype DX for adjuvant treatment decisions in women with early breast cancer. De Lima et al, 2019. PMID: 31287198 Selecting Patients for Oncotype DX Testing Using Standard Clinicopathologic Information. Robertson et al, 2019. PMID: 31551182

REaCT-Low Risk HER2	Comparing two chemotherapy treatments (TC-Herceptin vs weekly Paclitaxel + Herceptin) for low risk HER2 positive, early stage breast cancer. Principal Investigator(s): Dr. Terry Ng
ClinicalTrials.gov: NCT03705429
In a real-world population with either lower risk breast cancer or increased frailty (older patients, co-morbidities), assessing the relative benefits and toxicity of a chosen chemotherapy regimen is essential. This study compares TC-H chemotherapy with weekly P-H chemotherapy in low risk patients and will provide us with more information regarding cost-effectiveness, toxicity, quality of life, patient reported outcomes and clinical benefits of the two strategies.
Sites: London Health Sciences Centre The Ottawa Hospital
Tags: Early stage Breast Cancer
Publications: Clinical Trial results: A Multi-Centre Randomized Study Comparing Two Standard of Care Chemotherapy Regimens for Lower-Risk HER2-Positive Breast Cancer. Fernandes et al, 2023. PMID: 37623016

REaCT-RETT	Concurrent radiation + endocrine therapy vs sequential radiation + endrocrine therapy Principal Investigator(s): Dr. Jean-Marc Bourque and Dr. Sharon McGee
ClinicalTrials.gov: NCT03948568
After breast cancer surgery, patients receive either concurrent or sequential endocrine and radiation therapy, where concurrent therapy consists of endocrine therapy started before, with or during radiotherapy, while sequential treatment is defined as endocrine therapy starting after the completion of radiotherapy. This randomized clinical trial investigating the timing of adjuvant radiation and endocrine therapy in patients with early-stage breast cancer. Although these are established treatments received by a large proportion of breast cancer patients, the optimal timing remains unclear. This trial is comparing endocrine therapy given alongside, or following completion of, adjuvant radiotherapy, with key endpoints being endocrine therapy tolerance, and compliance.
Sites: Lakeridge Health (Oshawa) Markham Stouffville Hospital The Ottawa Hospital
Tags: Early stage Breast Cancer
Publications: Systematic Review: Optimal sequence of adjuvant endocrine and radiation therapy in early-stage breast cancer – A systematic review. McGee et al, 2019. PMID: 30014951 Physician Survey: Physician Survey of Timing of Adjuvant Endocrine Therapy Relative to Radiotherapy in Early Stage Breast Cancer Patients. McGee et al, 2019. PMID: 30318304 Clinical Trial results: A randomized trial evaluating endocrine toxicity with concurrent versus sequential radiation and endocrine therapy in early-stage, hormone responsive breast cancer. McGee et al. Under review

REaCT-ZOL	De-escalation of bone drugs (zoledronate infusion every 6 months for 3 years vs 1 zoledronate infusion) for patients with early stage breast cancer. Principal Investigator(s): Dr. Mark Clemons
ClinicalTrials.gov: NCT03664687
Patients with breast cancer are treated with an intravenous medication called zoledronate which helps keeps the bone strong, reduces the risk of fractures and has a small benefit in preventing breast cancer cells from going to the bone. This medication is associated with side effects such as feelings similar to a flu, bone pains and may rarely effect the kidneys and healing of the jaw bone. Previous clinical trials have shown that 7 doses of this medication is as effective as 19. We also know that these medications stay in the body/bone for a number of years even with a single dose. Based on this, we designed a clinical trial to assess whether 1 dose of this medication maybe as effective as 7 doses in which 211 patients have participated. We are currently following these patients.
Sites: Cancer Centre of Southeastern Ontario (Kingston, Juravinski Cancer Centre (Hamilton)) Southlake Regional Health Centre (Newmarket) The Ottawa Hospital William Osler Health Centre (Brampton)
Tags: Early stage Breast Cancer
Surveys Adjuvant bisphosphonate use in patients with early stage breast cancer: Patient perspectives on treatment acceptability and potential de-escalation. McGee et al, 2021. PMID: 33680749 Adjuvant bisphosphonate use in patients with early stage breast cancer: A physician survey. McGee et al, 2021. PMID: 33755864 Feasibility Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer. Awan et al, 2020. PMID: 33425673

REaCT-EF	Frequency of cardiac monitoring (echocardiogram or MUGA scan every 4 months vs. every 3 months) for patients with early stage breast cancer. Principal Investigator(s): Dr. John Hilton
ClinicalTrials.gov: NCT02696707
Several large adjuvant trastuzumab trials have demonstrated improved overall survival in patients with early stage breast cancer, with a 33% decrease in risk of death. However, retrospective analyses of patient outcomes in these trials have demonstrated increased risk of cardiotoxicity (i.e. damage to the heart) in a small number of patients. During a patient’s trastuzumab treatment, some oncologists order cardiac scans every 3 months while others order every 4 months. At this time, it is not known which standard monitoring schedule is optimal. This study has met accrual and follow-up is ongoing.
Sites: The Ottawa Hospital Thunder Bay Regional Health Sciences Centre
Tags: Early stage Breast Cancer
Publications: Clinical Trials results A Randomized Trial Comparing 3- versus 4-Monthly Cardiac Monitoring in Patients Receiving Trastuzumab-Based Chemotherapy for Early Breast Cancer. Dent et al, 2021. PMID: 34940066

REaCT-BTA	Frequency of treatment of bone targeted agents (every 4 weeks vs every 12 weeks) for patients with metastatic breast cancer or castration-resistant prostate cancer Principal Investigator(s): Dr. Mark Clemons
ClinicalTrials.gov: NCT02721433
Defining the optimal dosing interval of bone-targeted agents (BTA) for patients with bone metastases is an important question. This trial is comparing 4- versus 12-weekly therapy with any commonly used bone-targeted agent in patients with either metastatic breast or prostate cancer. This study has completed accrual and Year 2 follow up in ongoing.
Sites: Cancer Centre of Southeastern Ontario (Kingston) Cross Cancer Institute (Edmonton) London Health Sciences Centre The Ottawa Hospital Thunder Bay Regional Health Sciences Centre
Tags: Castration-resistant prostate cancer Metastatic breast cancer
Publications: Systematic Review: Should de-escalation of bone-targeting agents be standard of care for patients with bone metastases from breast cancer? A systematic review and meta-analysis. Ibrahim et al, 2015. PMID: 26122727 De-escalation of bone-modifying agents in patients with bone metastases from breast cancer: a systematic review and meta-analysis. Awan et al, 2019. PMID: 31079283 Patient and Physician Surveys: Bone-targeted agent use for bone metastases from breast cancer and prostate cancer: A patient survey. Hutton et al, 2013. PMID: 26909279 De-escalated administration of bone-targeted agents in patients with breast and prostate cancer-A survey of Canadian oncologists. Hutton et al, 2013. PMID: 26909274 Commentary and Meeting Abstracts: Dosing Strategies of Bone-Targeting Agents. Hutton et al, 2015. PMID: 26524744 The ZOOM trial: more boon than doom? Hutton et al, 2013. PMID: 23993380 A randomised trial of 4- versus 12-weekly administration of bone-targeted agents in patients with bone metastases from breast or castration-resistant prostate cancer. Clemons et al, 2019. ASCO 2019 Abstract 11501 Clinical Trial results: A randomised trial of 4- versus 12-weekly administration of bone-targeted agents in patients with bone metastases from breast or castration-resistant prostate cancer. Clemons et al, 2020. PMID: 33023785 Two-year results of a randomised trial comparing 4- versus 12-weekly bone-targeted agent use in patients with bone metastases from breast or castration-resistant prostate cancer. Clemons et al. 2021 PMID: 34567960

REaCT-G and G2	Duration of G-CSF treatment (5 days vs 7/10 days) during chemotherapy Principal Investigator(s): Dr. Mark Clemons
ClinicalTrials.gov: NCT02428114 NCT02816164
In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, the most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increase susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia (FN) can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of FN such as Neupogen (filgrastim) as a daily injection for 5, 7 or 10 days. Since there is genuine uncertainty among healthcare professionals as to which administration schedule of Neupogen is the best for patients, this randomized trial compared 5, 7 or 10 days of Neupogen.
Sites: Cancer Centre of Southeastern Ontario (Kingston) London Health Sciences Centre Northeast Cancer Centre (Sudbury) Southlake Regional Health Centre (Newmarket) The Ottawa Hospital Thunder Bay Regional Health Sciences Centre
Tags: Early stage Breast Cancer
Publications: Systematic Review: Primary Febrile Neutropenia Prophylaxis for Patients Who Receive FEC-D Chemotherapy for Breast Cancer: A Systematic Review. Fernandes et al, 2018. PMID: 30241156 Patient and Physician Surveys: Filgrastim use in patients receiving chemotherapy for early-stage breast cancer-a survey of physicians and patients. Hilton et al, 2018. PMID: 29411131 Clinical Trial results: A multi-center pragmatic, randomized, feasibility trial comparing standard of care schedules of filgrastim administration for primary febrile neutropenia prophylaxis in early-stage breast cancer. Ibrahim et al, 2017. PMID: 29214415 A multi-centre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer. Clemons et al, 2020. PMID: 32325257

REaCT-TC and TC2	Ciprofloxacin vs G-GCSF during chemotherapy Principal Investigator(s): Dr. Mark Clemons
ClinicalTrials.gov: NCT02173262 NCT02816112
A multi-centre study comparing granulocyte-colony stimulating factors to antibiotics for primary prophylaxis of docetaxel-cyclophosphamide induced febrile neutropenia.
Sites: Cross Cancer Institute (Edmonton) Northeast Cancer Centre (Sudbury) The Ottawa Hospital Tom Baker Cancer Centre (Calgary)
Tags: Early stage Breast Cancer
Publications: Systematic Review: Optimal primary febrile neutropenia prophylaxis for patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer: a systematic review. Fernandes et al, 2017. PMID: 27783280 Feasibility results: Feasibility of using a pragmatic trials model to compare two primary febrile neutropenia prophylaxis regimens (ciprofloxacin versus G-CSF) in patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer (REaCT-TC). Clemons et al, 2018. PMID: 30099602 Clinical Trial results: A multi-centre study comparing granulocyte-colony stimulating factors to antibiotics for primary prophylaxis of docetaxel-cyclophosphamide induced febrile neutropenia. Clemons et al. 2021 PMID: 33901921

REaCT-TNBC	Optimal chemotherapy for triple negative breast cancer Principal Investigator(s): Dr. John Hilton
ClinicalTrials.gov: NCT02688803
Triple-negative breast cancer (TNBC) is associated with a poorer prognosis than most other types of breast cancer. Despite chemotherapy being the only effective treatment in the curative setting, no one regimen has been identified as being optimal. This study evaluated the feasibility of comparing outcomes for the three most commonly used chemotherapy regimens (Dose dense AC-P vs. FEC-D vs. AC-weekly P) for this disease in an open-label, randomized study. Feasibility was not met in this study and it was closed.
Sites: The Ottawa Hospital
Tags: Early stage Breast Cancer
Publications: Clinical Trial results: Enhancing accrual to chemotherapy trials for patients with early stage triple-negative breast cancer: a survey of physicians and patients. Jacobs et al, 2017. PMID: 28127659

REaCT-VA HER2 negative	Peripheral vein access vs. insertion of a PICC central line for breast cancer patients receiving adjuvant HER2 negative chemotherapy Principal Investigator(s): Dr. Mark Clemons
ClinicalTrials.gov: NCT02688998
It is clear that several factors affect the likelihood a patient will receive a central line for chemotherapy, including: the different durations of commonly used chemotherapy regimens; whether or not the regimen includes an anthracycline; access to services for insertion of devices; patient preference; the ability of the Registered Nurse to locate and cannulate veins for peripheral access and physician practice.  Determining the optimal vascular access strategy remains an important medical issue for patients, nurses, physicians and society. This study is complete.
Sites: Cancer Centre of Southeastern Ontario (Kingston) The Ottawa Hospital
Tags: Early stage Breast Cancer
Publications: Systematic Review: Optimal vascular access strategies for patients receiving chemotherapy for early stage breast cancer: a systematic review. Robinson et al, 2018. PMID: 29974358 Surveys: Optimising vascular access for patients receiving intravenous systemic therapy for early stage breast cancer – A survey of oncology nurses and physicians. Levasseur et al, 2018. PMID: 30111975 Perceptions around vascular access for intravenous systemic therapy and risk factors for lymphedema in early stage breast cancer – A patient survey. Levasseur et al, 2018. PMID: 30111976 Clinical Trial results: A multicentre, randomized pilot trial comparing vascular access strategies for early stage breast cancer patients receiving non-trastuzumab containing chemotherapy. Robinson et al, 2019. PMID: 31392518

REaCT-VA HER2 positive	Central line access (PICC vs PORT) for breast cancer patients receiving adjuvant chemotherapy plus Herceptin Principal Investigator(s): Dr. Mark Clemons
ClinicalTrials.gov: NCT02632435
Intravenous trastuzumab is a common treatment regime for patients with early stage breast cancer. Adjuvant breast cancer chemotherapy require repeated visits to the chemotherapy unit and blood testing, along with trastuzumab treatment for 1 year. Thus vascular access devices are required to assist in efficient and effective treatment delivery and to improve patient experience. The best practice of type of vascular access is currently unknown (PICC vs. PORT).  This study is complete.
Sites: The Ottawa Hospital
Tags: Early stage Breast Cancer
Publications: Systematic Review: A randomized trial comparing vascular strategies for patients receiving chemotherapy trastuzumab for early-stage breast cancer. Clemons et al, 2020. PMID: 32002617

REaCT-DEX	Missed dexamethasone premedication during docetaxel chemotherapy Principal Investigator(s): Dr. Tina Hsu
ClinicalTrials.gov: NCT02815319
Docetaxel chemotherapy is commonly used in breast cancer patients, however side effects are common, including acute hypersensitivity reactions, capillary leak syndrome and skin toxicities. Steroid premedication is given with docetaxel chemotherapy to prevent many of these side effects. Currently there is no standard of care procedure if a patient forgets to take any or all of their steroid premedication. This can lead to significant treatment delays while the patient waits for the CTU nurse to contact the treating physician, obtain a replacement strategy and then fill the order with pharmacy.  This study compares a set replacement regimen with physician’s choice regimen in the hopes of reducing the wait time for chemotherapy. This study is complete
Sites: The Ottawa Hospital
Tags: None
Publications: Survey: Optimisation of steroid prophylaxis schedules in breast cancer patients receiving docetaxel chemotherapy-a survey of health care providers and patients. Jacobs et al, 2015. PMID: 25933700 Clinical Trial results: A randomised clinical trial comparing physician-directed or fixed-dose steroid replacement strategies for incomplete dexamethasone dosing prior to docetaxel chemotherapy. Hsu et al, 2020. PMID: 33057999

REaCT-ADM	Comparison of acellular dermal matrices in breast reconstruction surgery Principal Investigator(s): Dr. Angel Arnaout
ClinicalTrials.gov: NCT03064893
Acellular dermal matrix (ADM) are increasingly used in breast reconstruction after mastectomy. Various ADMs are available on the market with varying costs despite similar quality. The two most commonly used ADM products in North America are Alloderm and Dermacell, each of which have been shown to be safe and effective and are equally available in Canadian hospitals. The aim of this study is to evaluate the postsurgical complications of Alloderm vs Dermacell use in immediate breast reconstruction.  This study has been completed.
Sites: The Ottawa Hospital
Tags: None
Publications: A Randomized Controlled Trial Comparing Alloderm-RTU with DermACELL in Immediate Subpectoral Implant-Based Breast Reconstruction. Arnaout et al, 2020. A Randomized Controlled Trial Comparing Alloderm-RTU with DermACELL in Immediate Subpectoral Implant-Based Breast Reconstruction

REaCT-Mg	Magnesium replacement strategies for patients receiving palliative-intent treatment with Cisplatin, Carboplatin, Panitumumab or Cetuximab  Principal Investigator(s): Dr. Michael Vickers
ClinicalTrials.gov: NCT02690012
Hypomagnesemia is a common consequence of many anti-cancer therapies. However optimal replacement strategies are unknown. The trial assessed the feasibility of comparing the benefits of treating hypomagnesemia to magnesium oxide or magnesium citrate in patients receiving palliative treatment with cisplatin, carboplatin, Panitumumab or Cetuximab. This study has been completed.
Sites: The Ottawa Hospital
Tags: Palliative chemotherapy
Publications: A comparison of oral magnesium supplements for cancer treatment-induced hypomagnesemia: results from a pilot randomized trial. Vickers et al. 2021. PMID: 34938893