Randomized Anastrozole Exercise Trial (RAE)
This is a randomized, phase III trial of a 12 week exercise program, followed by a 36 week voluntary, self-directed exercise program (total 48 weeks) compared to standard supportive care. The purpose of the trial is to determine whether the exercise program is better than standard supportive care to decrease the muscle and joint aches (musculoskeletal symptoms) that result from aromatase inhibitors.
Hypothesis An exercise program that includes stretching, strengthening and aerobic components may improve physical quality of life among women with musculoskeletal symptoms who are taking aromatase inhibitors.
Other: Supportive Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Anastrozole Exercise Trial (The RAE Study)|
- The primary endpoint is the mean SF36 physical component summary (PCS) score for subjects in each study Arm after 12 weeks.
- Difference in musculoskeletal symptoms as measured by VAS and NCIC-CTC toxicity criteria.
- Global QOL: As measured by SF36 and VAS composite scores at each scheduled follow up visit (Baseline, weeks 4,8,12,24,36,48). See Appendix B for instruments.
- Hot Flashes: A hot flash scale will be given to subjects to complete at each scheduled follow up visit (baseline, week 4,8,12,24,36,48). Severity and frequency of hot flashes will be compared between the exercise and control groups at each time point
- 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.
- Bone Mineral Density.
- 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.
|Study Start Date:||December 2007|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: A
Arm A: Standard Supportive Care (no supervised exercise)
|Other: Supportive Care|
Arm B: Exercise Intervention
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519883
|Canada, British Columbia|
|BC Cancer Agency Vancouver Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|BC Cancer Agency Vancouver Island|
|Victoria, British Columbia, Canada, V8R 6V5|
|Principal Investigator:||Hagen Kennecke, MD||BC Cancer Agency Vancouver Centre|
|Principal Investigator:||Caroline Lohrisch, MD||BC Cancer Agency - Vancouver Centre|