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High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02923401
Recruitment Status : Active, not recruiting
First Posted : October 4, 2016
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


Condition or disease Intervention/treatment Phase
Disorders of Breast Other: Exercise Behavioral: Questionnaires Behavioral: Motivational Session Behavioral: Phone Call Other: Printed Materials Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer
Actual Study Start Date : September 30, 2016
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High-Intensity Interval Training (HIIT) Group

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.

Other: Exercise

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.


Behavioral: Questionnaires
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.
Other Name: Surveys

Behavioral: Motivational Session
One (1) time each month, participant attends a motivational session for 12 weeks.

Other: Printed Materials

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.


Experimental: Moderate-Intensity Continuous Training (MICT) Group

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.

Other: Exercise

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.


Behavioral: Questionnaires
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.
Other Name: Surveys

Behavioral: Motivational Session
One (1) time each month, participant attends a motivational session for 12 weeks.

Other: Printed Materials

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.


Active Comparator: Control Group

Participants 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.

Behavioral: Questionnaires
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.
Other Name: Surveys

Behavioral: Motivational Session
One (1) time each month, participant attends a motivational session for 12 weeks.

Behavioral: Phone Call
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.




Primary Outcome Measures :
  1. Feasibility of High-Intensity Interval Exercise to Offset the Tumor Promoting Effects of Obesity in High-Risk Breast Cancer Participants [ Time Frame: 12 weeks ]

    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%.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923401


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Susan C. Gilchrist, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02923401    
Other Study ID Numbers: 2016-0442
NCI-2016-01938 ( Registry Identifier: NCI CTRP )
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Keywords provided by M.D. Anderson Cancer Center:
Exercise
Biomarkers
Breast cancer high risk
Treadmill
Stationary bicycle
Questionnaires
Surveys
Motivational sessions
Phone calls
Printed materials
Additional relevant MeSH terms:
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Breast Diseases
Skin Diseases