Randomized Anastrozole Exercise Trial (RAE)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by British Columbia Cancer Agency.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
British Columbia Cancer Agency
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00519883
First received: August 22, 2007
Last updated: August 25, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Musculoskeletal Symptoms |
Other: Exercise Other: Supportive Care |
Phase 3 |
| Study Type: | Interventional |
| 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) |
Resource links provided by NLM:
Further study details as provided by British Columbia Cancer Agency:
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:
- 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.
| Estimated Enrollment: | 72 |
| Study Start Date: | December 2007 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Arm A: Standard Supportive Care (no supervised exercise)
|
Other: Supportive Care |
|
Experimental: B
Arm B: Exercise Intervention
|
Other: Exercise |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women who have been on an adjuvant AI for at least 6 weeks.
- The presence of some musculoskeletal symptoms.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1
- ER and or PgR positive early breast cancer, stages I, II or III
- Completion of any adjuvant chemotherapy (if given) and primary breast cancer surgery.
- Be willing to switch to Anastrozole if on another AI
- Signed written informed consent
Exclusion Criteria:
- Metastatic disease (no imaging or labs required in absence of clinical suspicion of metastases)
- Evidence or history of inflammatory arthropathy (for example, rheumatoid arthritis)
- Any medical condition (for example, significant heart disease) that would prevent a subject from completing an exercise program.
- Unable to take Aromatase Inhibitor (AI)
- Planned secondary reconstruction procedures during the 48 week study period
- Any medical, physical, geographic, emotional, or economic condition that in the judgement of the clinician/study doctor, would make an individual unable or unlikely to be able to exercise three times a week for 12 weeks.
- Unable to complete a study log book and questionnaires (unable to read and write English and no one at home who can adequately do so).
- The use of any exogeneous estrogen and/or progesterone except Estring and natural plant estrogens
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519883
Locations
| 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 | |
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
| Principal Investigator: | Hagen Kennecke, MD | BC Cancer Agency Vancouver Centre |
| Principal Investigator: | Caroline Lohrisch, MD | BC Cancer Agency - Vancouver Centre |
More Information
No publications provided
| Responsible Party: | Dr Hagen Kennecke, BC Cancer Agency - Vancouver Centre |
| ClinicalTrials.gov Identifier: | NCT00519883 History of Changes |
| Other Study ID Numbers: | RAE Study |
| Study First Received: | August 22, 2007 |
| Last Updated: | August 25, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by British Columbia Cancer Agency:
|
Anastrozole Exercise |
Additional relevant MeSH terms:
|
Anastrozole Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013