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Exercise Program for Musculoskeletal Pain (RAE Trial)

Phase 3
Waitlist Available
Led By Hagen Kennecke, MD
Research Sponsored by British Columbia Cancer Agency
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Completion of any adjuvant chemotherapy (if given) and primary breast cancer surgery.
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

RAE Trial Summary

This trial will compare a 12-week exercise program to standard supportive care. The goal is to see if the exercise program can decrease the muscle and joint aches that can be a side effect of taking aromatase inhibitors.

Who is the study for?
This trial is for women with early-stage breast cancer (I, II, or III) who are experiencing muscle and joint aches from taking aromatase inhibitors. Participants must have completed any prior chemotherapy and surgery, be able to perform exercises, and consent to switch to Anastrozole if using another AI.Check my eligibility
What is being tested?
The study compares a 12-week exercise program followed by self-directed exercise for an additional 36 weeks against standard supportive care in reducing musculoskeletal pain caused by aromatase inhibitors in breast cancer patients.See study design
What are the potential side effects?
While the trial itself does not involve medication that would cause side effects, exercising may lead to typical discomforts such as muscle soreness or fatigue. Any serious health issues related to the exercise regimen will be monitored.

RAE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have finished all treatments and surgery for my breast cancer.
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I am fully active or have some restrictions but can still care for myself.
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My breast cancer is ER or PgR positive and in stage I, II, or III.
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I have finished all my breast cancer surgery and any additional chemotherapy.

RAE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary endpoint is the mean SF36 physical component summary (PCS) score for subjects in each study Arm after 12 weeks.
Secondary outcome measures
Arm Circumferences: Arm circumferences will be measured for all subjects on both arms as described in Appendix D at each study follow up visit except weeks 4, 8, and 36.
Body Mass Weight, in kilograms, will be recorded for all subjects at baseline and at weeks 4,8,12,24,36, and 48 week visits.
Bone Mineral Density.
+3 more

RAE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BExperimental Treatment1 Intervention
Arm B: Exercise Intervention
Group II: AActive Control1 Intervention
Arm A: Standard Supportive Care (no supervised exercise)

Find a Location

Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor
171 Previous Clinical Trials
90,439 Total Patients Enrolled
Hagen Kennecke, MDPrincipal InvestigatorBC Cancer Agency Vancouver Centre
6 Previous Clinical Trials
646 Total Patients Enrolled
Caroline Lohrisch, MDPrincipal InvestigatorBC Cancer Agency - Vancouver Centre

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT00519883 — Phase 3
Musculoskeletal Pain Research Study Groups: B, A
Musculoskeletal Pain Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT00519883 — Phase 3
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT00519883 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators looking for more participants in this clinical trial?

"According to the latest information available on clinicaltrials.gov, this trial is not currently recruiting patients. The study was posted on December 1st, 2007 and edited on August 21st, 2014. Although this particular trial isn't enrolling participants right now, there is one other similar study that is actively searching for candidates."

Answered by AI

Has the FDA given their stamp of approval to Exercise as a treatment method?

"Exercise is considered safe based on available data from previous trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Randomized Anastrozole Exercise Trial
2007. "Randomized Anastrozole Exercise Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00519883.
~4 spots leftby Apr 2025
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