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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

Must not have

History of eating disorder (diagnosed or self-reported)

Unable to provide informed consent (i.e. cognitive impairment)

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of an eating disorder.

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I am able to understand and agree to the study's procedures and risks.

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I need extra oxygen.

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I weigh more than 109 kg.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.