Clinical trial · Interventional
Hormones and Physical Exercise (HOPE) Study
NCT02056067CI-TRIAL-00043840completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthralgia | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Attention Control (Health Education) | Behavioral | — | UNRESOLVED |
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise
- description
- The exercise intervention group will receive social, behavioral support and research staff contact time to encourage them to increase their activity level to include twice weekly strength-training sessions and 150 min of walking/week (e.g., three 50-min walking sessions or five 30-min walking sessions) over 12 months.
- interventionNames
- Behavioral: Exercise
- type
- ACTIVE_COMPARATOR
- label
- Attention Control (Health Education)
- description
- The Attention Control Group will be provided written information that emphasizes the importance of a healthy lifestyle. Participants will be encouraged to follow the NCI and ACS physical activity guidelines. This procedure was followed in our exercise trials, with no increase in physical activity levels observed at follow-up among women in the usual care group. Attention Control participants will also receive frequent contacts throughout the 12 month intervention. Each month, women randomized to attention control will be contacted by phone to discuss a health education topic of interest
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDThomas 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. PMID 28026901
- DERIVEDIrwin 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. PMID 25452437