Hormones and Physical Exercise (HOPE) Study
Completed · Not applicable
Conditions studied: Breast Cancer, Arthralgia
In brief
The investigators propose to examine 121 postmenopausal women diagnosed with hormone-receptor positive breast cancer who have been taking aromatase inhibitors (AI) for at least 6 months and are experiencing at least mild arthralgia originating during AI treatment, the yearlong effect of exercise vs. attention control (health education), and on toxic side effects of AI.
Key facts
- Study ID
- NCT02056067
- Run by
- Yale University
- People needed
- 121
- Starts
- 2009-06-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2020-03-05
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Postmenopausal women (defined as the surgical or natural absence of menstrual cycles for at least 1 year prior to breast cancer diagnosis).
- 75 years or younger
- AJCC Stages I-IIIC Breast Cancer
- Taking an AI for at least 2 months
- Currently experiencing at least mild arthralgia (= or > 3 on the BPI) associated with AI use
- Physically able to exercise and physician consent to start an exercise program
- Sedentary activity pattern (< 90 mins/week of moderate-to-vigorous intensity sports activity) within the past year and low fitness level
- No more than one strength training session per week within the past year
- Agrees to be randomly assigned to either exercise or attention control
- Gives informed consent to participate in all study activities
- Able to come for baseline, 6-, and 12-month clinic visits and strength training sessions (6-month intervention study - able to come for baseline, 6-month clinic visits and strength training sessions).
- Mentally competent
You may not qualify if…
- Lymphedema with self reported 'flare up' in the past 4 months
Where it is running
- Yale University — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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