Clinical trial · Interventional
High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer
NCT02923401CI-TRIAL-00056775completedN/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 goal of this research study is to learn if there is a level of exercise training that is more effective in lowering biomarker levels that are linked to breast cancer risk. Biomarkers are found in the blood/tissue and may be related to your reaction to exercise. This is an investigational study. Up to 72 participants will be enrolled in this study. All will take part at MD Anderson.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disorders of Breast | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Other | — | UNRESOLVED |
| Motivational Session | Behavioral | — | UNRESOLVED |
| Phone Call | Behavioral | — | UNRESOLVED |
| Printed Materials | Other | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- High-Intensity Interval Training (HIIT) Group
- description
- Participants come to the Energy Balance Center to exercise 3 times a week for 12 weeks. Participants receive written materials and instructions on how to perform their exercises. Participants walk uphill on a treadmill for a total of 33 minutes 3 times a week for 12 weeks. Participants complete questionnaires about their quality of life, exercise experience, and level of fatigue at baseline and at 12 weeks. One (1) time each month, participant attends a motivational session.
- interventionNames
- Other: Exercise
- Behavioral: Questionnaires
- Behavioral: Motivational Session
- Other: Printed Materials
- type
- EXPERIMENTAL
- label
- Moderate-Intensity Continuous Training (MICT) Group
- description
- Participants come to the Energy Balance Center to exercise 3 times a week for 12 weeks. Participants receive written materials and instructions on how to perform their exercises. Participants walk uphill on a treadmill or use a stationary bicycle continuously for 41 minutes 3 times a week for 12 weeks. Participants complete questionnaires about their quality of life, exercise experience, and level of fatigue at baseline and at 12 weeks. One (1) time each month, participant attends a motivational session.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Postmenopausal women \[defined per provider discretion and notated in the medical record\] 2. At high risk of developing breast cancer (history of Ductal Carcinoma In Situ (DCIS), Lobular Carcinoma In Situ (LCIS), Atypical Ductal Hyperplasia (ADH), Gail 5 year risk \> 1.66% or lifetime risk \> 20%) 3. Enrolled on the Longitudinal High Risk Cohort study or being seen in the Cancer Prevention Center. 4. Oriented to person, place, and time 5. BMI \> or equal to 25 kg/m2 6. Speaks and reads English Exclusion Criteria: 1. Underlying medical problems that contraindicate unsupervised exercise. 2. Women with a prior history of cardiovascular disease, defined as a 1 or more positive responses on the Heart Questionnaire (Appendix D). 3. Uses a walker or wheelchair/scooter 4. Is being treated for diagnosed diabetes or autoimmune disease 5. Lives outside the greater Houston area (Harris and contiguous counties) 6. Is pregnant (self-reported) 7. Is taking risk reduction therapy such as tamoxifen 8. Participants with a blood pressure \>=140/90 at the time of baseline testing.
References
Publications (1)
- DERIVEDColetta AM, Agha NH, Baker FL, Niemiro GM, Mylabathula PL, Brewster AM, Bevers TB, Fuentes-Mattei E, Basen-Engquist K, Gilchrist SC, Simpson RJ. The impact of high-intensity interval exercise training on NK-cell function and circulating myokines for breast cancer prevention among women at high risk for breast cancer. Breast Cancer Res Treat. 2021 Jun;187(2):407-416. doi: 10.1007/s10549-021-06111-z. Epub 2021 Feb 8. PMID 33555464