Clinical trial NCT02056067: Hormones and Physical Exercise (HOPE) Study
Official title: Hormones and Physical Exercise (HOPE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Arthralgia
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-02-05
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Arthralgia Severity
timeFrame: 6 months
measure: Change from Baseline in Arthralgia Severity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Melinda Irwin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas GA, Cartmel B, Harrigan M, Fiellin M, Capozza S, Zhou Y, Ercolano E, Gross CP, Hershman D, Ligibel J, Schmitz K, Li FY, Sanft T, Irwin ML. The effect of exercise on body composition and bone mineral density in breast cancer survivors taking aromatase inhibitors. Obesity (Silver Spring). 2017 Feb;25(2):346-351. doi: 10.1002/oby.21729. Epub 2016 Dec 27.
citation: Irwin ML, Cartmel B, Gross CP, Ercolano E, Li F, Yao X, Fiellin M, Capozza S, Rothbard M, Zhou Y, Harrigan M, Sanft T, Schmitz K, Neogi T, Hershman D, Ligibel J. Randomized exercise trial of aromatase inhibitor-induced arthralgia in breast cancer survivors. J Clin Oncol. 2015 Apr 1;33(10):1104-11. doi: 10.1200/JCO.2014.57.1547. Epub 2014 Dec 1.