High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer
2 other identifiers
interventional
39
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2016
CompletedFirst Submitted
Initial submission to the registry
October 3, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2022
CompletedFebruary 28, 2022
February 1, 2022
5.3 years
October 3, 2016
February 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of High-Intensity Interval Exercise to Offset the Tumor Promoting Effects of Obesity in High-Risk Breast Cancer Participants
Trials judged feasible if: At least 45% of screened patients meet inclusion criteria, 2. At least 50% of patients who meet the inclusion criteria consent, 3. Adherence in HIIT and MICT is larger than 80%, and 4. Retention rate is larger than 80%.
12 weeks
Study Arms (3)
High-Intensity Interval Training (HIIT) Group
EXPERIMENTALParticipants 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.
Moderate-Intensity Continuous Training (MICT) Group
EXPERIMENTALParticipants 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.
Control Group
ACTIVE COMPARATORParticipants receive written materials and counseling by an exercise physiologist. Participants called by a member of the study staff 1 time each week for 12 weeks and asked about any exercise they have done and their weight loss goals. 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.
Interventions
High-Intensity Interval Training (HIIT) Group: Participants walk uphill on a treadmill for a total of 33 minutes 3 times a week for 12 weeks.There is a 5-minute warm up, followed by four 4-minute intervals. Between each interval, participant walks for 3 minutes. There is a 3 minute cool down. Moderate-Intensity Continuous Training (MICT) Group: 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. These should take a total of about 15 minutes to complete.
One (1) time each month, participant attends a motivational session for 12 weeks.
Participants called by a member of the study staff 1 time each week for 12 weeks and asked about any exercise they have done and their weight loss goals. Each phone call should take about 15 minutes.
High-Intensity Interval Training (HIIT) Group and Moderate-Intensity Continuous Training (MICT) Group: Participants receive written materials and instructions on how to perform their exercises. Control Group: Participants receive written materials and counseling by an exercise physiologist.
Eligibility Criteria
You may qualify if:
- Postmenopausal women \[defined per provider discretion and notated in the medical record\]
- 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%)
- Enrolled on the Longitudinal High Risk Cohort study or being seen in the Cancer Prevention Center.
- Oriented to person, place, and time
- BMI \> or equal to 25 kg/m2
- Speaks and reads English
You may not qualify if:
- Underlying medical problems that contraindicate unsupervised exercise.
- Women with a prior history of cardiovascular disease, defined as a 1 or more positive responses on the Heart Questionnaire (Appendix D).
- Uses a walker or wheelchair/scooter
- Is being treated for diagnosed diabetes or autoimmune disease
- Lives outside the greater Houston area (Harris and contiguous counties)
- Is pregnant (self-reported)
- Is taking risk reduction therapy such as tamoxifen
- Participants with a blood pressure \>=140/90 at the time of baseline testing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Coletta 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: 33555464DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan C. Gilchrist, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2016
First Posted
October 4, 2016
Study Start
September 30, 2016
Primary Completion
January 5, 2022
Study Completion
January 5, 2022
Last Updated
February 28, 2022
Record last verified: 2022-02