Randomized Anastrozole Exercise Trial

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Anastrozole Exercise Trial (The RAE Study)

Conditions
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Musculoskeletal Symptoms

Intervention / Treatment
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* Other: Exercise
* Other: Supportive Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Arm A: Standard Supportive Care (no supervised exercise) | Other: Supportive Care<br> <br> |
| Experimental: B<br>Arm B: Exercise Intervention | Other: Exercise<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the mean SF36 physical component summary (PCS) score for subjects in each study Arm after 12 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anastrozole, Exercise