Hormones and Physical Exercise (HOPE) Study

Not Applicable

Completed

• Conditions: Arthralgia; Breast Cancer

• Registration Number: NCT02056067
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

The investigators propose to examine, in 121 postmenopausal breast cancer survivors who have been taking an AI for at least 2 months and are currently experiencing at least mild arthralgia associated with AI use, the effect of a randomized controlled exercise intervention vs. attention control (health education) on severity of arthralgia, endocrine-related Quality of Life(QOL), Bone Mineral Density(BMD), and mediators/mechanisms influencing the effect of exercise on arthralgia severity. Women will be randomized to a year long exercise program or attention control group. Women randomized to exercise will participate in 150 min/wk of aerobic exercise and a twice-weekly strength training program. The investigators will conduct baseline, six-, and 12-month clinic visits, as well as a 3- and 9-month mailing to evaluate the effect of the intervention on study outcomes.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

Inclusion Criteria

• 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

Exclusion Criteria

• Lymphedema with self reported 'flare up' in the past 4 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Arthralgia Severity	12 months	Measured using the Brief Pain Inventory (BPI). Subjects are asked to rate pain by circling a number from 0-10 that describes pain at its "worst", "least", and "average" with 0 being no pain and 10 being "pain as bad as you can imagine".

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States