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Aerobic Exercise for Breast Cancer (ACTIVATE Trial)

N/A

Waitlist Available

Led By Kristin L Campbell, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-chemotherapy (baseline, week 0), mid-chemotherapy (week 6-9), end of chemotherapy (12-18 weeks post-baseline), follow-up/post-usual care group receiving intervention (24-34 weeks post-baseline),1-year follow-up (52 weeks post-baseline).

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether aerobic exercise can help prevent or mitigate chemotherapy-related cognitive changes (CRCC) in women with breast cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-chemotherapy (baseline, week 0), mid-chemotherapy (week 6-9), end of chemotherapy (12-18 weeks post-baseline), follow-up/post-usual care group receiving intervention (24-34 weeks post-baseline),1-year follow-up (52 weeks post-baseline).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-chemotherapy (baseline, week 0), mid-chemotherapy (week 6-9), end of chemotherapy (12-18 weeks post-baseline), follow-up/post-usual care group receiving intervention (24-34 weeks post-baseline),1-year follow-up (52 weeks post-baseline).

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-chemotherapy (baseline, week 0), mid-chemotherapy (week 6-9), end of chemotherapy (12-18 weeks post-baseline), follow-up/post-usual care group receiving intervention (24-34 weeks post-baseline),1-year follow-up (52 weeks post-baseline). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neuropsychological Tests

Secondary study objectives

Change with treatment and maintenance post-treatment in brain function and structure

Change with treatment and maintenance post-treatment in electrical activity of the brain

Change with treatment and maintenance post-treatment in self-reported cognitive function

+1 more

Other study objectives

Change in exercise behaviour

Change with treatment and maintenance post-treatment in aerobic fitness

Change with treatment and maintenance post-treatment in body composition

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual Care (Wait-list Control)Experimental Treatment1 Intervention

Participants randomly assigned to UC group will be advised to continue with their regular activities of daily living. Following their chemotherapy, the UC group will receive the exercise intervention (lasting 12 weeks).

Group II: Aerobic ExerciseExperimental Treatment1 Intervention

Participants will complete three supervised aerobic exercise sessions each week using the treadmill, stationary bicycle or elliptical training for the duration of their chemotherapy (12-18 weeks). Aerobic exercise will be performed for 20-40 minutes at 50-75% of heart rate reserve. Participants will wear heart rate monitors during all supervised sessions (Polar Electro Inc., Lake Success, NY) and will be provided with target heart rates that will be individualized using their baseline (i.e., week 0) assessment data. Home-based exercise will be introduced in week 3. For the home-based sessions, participants will be asked to complete at least 1 session per week of 30 minutes of aerobic exercise (an activity of their choosing; e.g., walking).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic Exercise

2013

Completed Early Phase 1

~1350

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