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Diet and Exercise for Breast Cancer (DREAM Trial)
N/A
Waitlist Available
Led By Richard Thompson, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Starting (or having only received one treatment of) any type of intravenously administered chemotherapy
Diagnosis of stage IV or metastatic breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-6 weeks before the first chemotherapy treatment of the first cycle and 1-3 weeks after the last chemotherapy treatment of the third cycle
Awards & highlights
DREAM Trial Summary
This trial will test whether an intervention of aerobic exercise and caloric restriction can improve outcomes for people with metastatic breast cancer.
Who is the study for?
This trial is for adults over 18 with stage IV or metastatic breast cancer who are starting or have had one chemotherapy treatment. Participants must be able to perform some exercise, follow a special diet, and not have severe kidney issues, diabetes, extreme weight loss, strict dietary restrictions like veganism, or any condition that would limit exercise like bone metastases.Check my eligibility
What is being tested?
The study tests if a combination of aerobic exercise during chemo infusions and a low-carb diet before each treatment can improve outcomes in metastatic breast cancer patients. Fifty participants will either receive this intervention alongside their regular chemo or just the usual care without these additions.See study design
What are the potential side effects?
Potential side effects may include fatigue from the exercise regimen and possible nutritional deficiencies due to caloric restriction. The impact on quality of life and symptoms will be monitored through questionnaires.
DREAM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am starting or have had only one round of chemotherapy given through my veins.
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My breast cancer has spread to other parts of my body.
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My cancer has spread and can be measured.
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I am older than 18 years.
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I can take care of myself but might not be able to do heavy physical work.
DREAM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-6 weeks before the first chemotherapy treatment of the first cycle and 1-4 weeks after the last chemotherapy treatment of the last cycle
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-6 weeks before the first chemotherapy treatment of the first cycle and 1-4 weeks after the last chemotherapy treatment of the last cycle
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tumor size change after 6 cycles (mm)
Secondary outcome measures
Tumor response to therapy by magnetic resonance imaging (mm²/s)
Tumor size change after 3 cycles (mm)
Other outcome measures
Fatigue
Left ventricular ejection fraction (%)
Left ventricular global longitudinal strain (%)
+10 moreDREAM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Standard chemotherapy treatment and oncology care plus short-term diet and exercise intervention.
Group II: Control GroupActive Control1 Intervention
Standard chemotherapy treatment and oncology care.
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
888 Previous Clinical Trials
384,935 Total Patients Enrolled
13 Trials studying Breast Cancer
2,260 Patients Enrolled for Breast Cancer
Canadian Cancer Society (CCS)OTHER
78 Previous Clinical Trials
37,722 Total Patients Enrolled
7 Trials studying Breast Cancer
608 Patients Enrolled for Breast Cancer
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,343 Previous Clinical Trials
26,453,070 Total Patients Enrolled
10 Trials studying Breast Cancer
4,747 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have difficulty exercising due to bone issues.I am starting or have had only one round of chemotherapy given through my veins.I have a history of an eating disorder.You have severe allergies to certain foods.Your bilirubin levels are higher than 30 umol/L.My breast cancer has spread to other parts of my body.My cancer has spread and can be measured.I am older than 18 years.Your creatinine level is higher than 120 umol/L.I have diabetes.My doctor is concerned about my weight loss due to cancer.I am able to understand and agree to the study's procedures and risks.My doctor has approved my participation despite my controlled pleural effusions.I need extra oxygen.I weigh more than 109 kg.I can take care of myself but might not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the status of enrollment for this clinical trial?
"The information found on clinicaltrials.gov shows that this particular research trial is not currently seeking participants, even though it has been continually updated since its first posting in April 23rd 2019. However, 2602 other studies are actively recruiting at the moment."
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