Disorders of BreastNCT02923401
High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer
A study testing Exercise, Questionnaires and Motivational Session in people with Disorders of Breast, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disorders of Breast
- What is being tested?
- Exercise, Questionnaires and Motivational Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2016to 5 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the detailed description
Study Groups:
If you agree to take part in this research study, you will be randomly assigned (as in a roll of dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to each group:
- If you are in Group 1, you will take part in high-intensity interval (HIIT) exercise.
- If you are in Group 2, you will take part in moderate-intensity exercise.
- If you are in Group 3, you will not take part in any assigned exercise, but you will receive written materials and counseling by an exercise physiologist.
If you are in Group 1 or Group 2, you will also receive written materials and instructions on how to perform your exercises.
Physical Activity:
If you are in Group 1 or 2, you will come to the Energy Balance Center to exercise 3 times a week for 12 weeks.
If you are in Group 1, you will walk uphill on a treadmill for a total of 33 minutes. There will be a 5-minute warm up, followed by four 4-minute intervals. Between each interval, you will walk for 3 minutes. There will be a 3 minute cool down.
If you are in Group 2, you will exercise at the Energy Balance Center 3 times a week. You will walk uphill on a treadmill or use a stationary bicycle continuously for 41 minutes.
If you are in Group 3, 1 time each month while you are on study, you will be called by a member of the study staff and asked about any exercise you have done and your weight loss goals. Each phone call should take about 15 minutes.
The exercise training intensity may be reduced or stopped temporarily if you experience side effects.
Length of Study:
No matter which group you are in, your participation in this study will be over after 12 weeks. You will be taken off study if you have intolerable side effects.
Study Visits:
All participants will visit the MD Anderson Behavioral Research and Treatment Center for each study visit.
At baseline:
- You will have a cardiopulmonary exercise test (CPET) to check your lung function. The CPET checks how well your lungs are working by measuring how much oxygen and carbon dioxide your lungs take in and release when you breathe. To perform this test, you will be asked to walk on a treadmill until you reach a point that you can no longer exercise. You will be breathing into the machine while you walk. This test will take about 30 minutes to complete. The study doctor will be present for each CPET and available to respond to any complication.
- You will have an EKG to check your heart function. The study doctor will be present for each EKG you have.
- Blood (about 1½ tablespoons) will be drawn for biomarker testing. You will be asked to fast (eat nothing and drink only water) for at least 12 hours before each blood draw as part of this study.
- You will have a dual-energy x-ray absorptiometry (DEXA) scan to measure your body mass.
- You will complete a questionnaire that will ask you about your demographics (age, race, and so on), past medical history, and lifestyle habits. This questionnaire should take about 5 minutes to complete.
- You will complete 5 questionnaires about your quality of life, exercise experience, and level of fatigue. These should take a total of about 15 minutes to complete.
At 6 weeks:
- You will have a CPET.
- You will have an EKG.
At 12 weeks:
- You will have a CPET.
- Blood (about 1½ tablespoons) will be drawn for biomarker testing.
- You will have an EKG.
- You will have a DEXA scan.
- You will complete the same questionnaires that you completed at baseline.
- If you are in Group 1 or 2, you will be interviewed by a member of the study staff. You will be asked 5 questions about your experience with your assigned exercise program. It should take about 5 minutes to complete.
One (1) time each month, you will attend a motivational session. During this session, you will discuss strategies for overcoming barriers that may be keeping you from attending or completing your exercises. You will also talk about continuing physical activity after you complete the program. This session should last about 15-30 minutes.
Additional Information:
- Trained health professionals will be present at all study visits to address any symptoms during exercise. If you feel that you are having difficulty breathing, experiencing dizziness, or are having any heart related symptoms while exercising at home, please stop exercising and call 911 immediately.
- Clinical information such as your name, patient medical record number, age, gender, body mass index (BMI), zip code, and your complete medical history will be collected from your medical record.
- If you are in Group 1 or Group 2, you will receive text messages before each exercise session to remind you to attend. You will be responsible for any text messaging charges. Standard text message rates will apply.
- Conditions
- Disorders of Breast
- Being tested
- Exercise, Questionnaires, Motivational Session, Phone Call, Printed Materials
- Keywords
- Exercise, Biomarkers, Breast cancer high risk, Treadmill, Stationary bicycle, Questionnaires, Surveys, Motivational sessions, Phone calls, Printed materials
- Medical subject headings
- Breast Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
QuestionnairesBehavioural
Also called Surveys
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.
Motivational SessionBehavioural
One (1) time each month, participant attends a motivational session for 12 weeks.
Phone CallBehavioural
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.
Printed MaterialsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training (HIIT) Group | Experimental | 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. Receives: Other: Exercise; Behavioral: Questionnaires; Behavioral: Motivational Session; Other: Printed Materials |
| Moderate-Intensity Continuous Training (MICT) Group | Experimental | 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. Receives: Other: Exercise; Behavioral: Questionnaires; Behavioral: Motivational Session; Other: Printed Materials |
| Control Group | Active comparator | 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. Receives: Behavioral: Questionnaires; Behavioral: Motivational Session; Behavioral: Phone Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start30 Sep 2016
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorders of BreastStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan C. Gilchrist, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923401
- Sponsor's protocol ID
- 2016-0442
- Other IDs
- NCI-2016-01938
- Status last verified
- Feb 2022
- First submitted
- 3 Oct 2016
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33555464
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Interval Training for Women at Heightened Risk for Breast Cancer
- ClinicalTrials.gov ID
- NCT02923401
- Acronym / sponsor ID
- 2016-0442
- Conditions
- Disorders of Breast
- Keywords
- Exercise, Biomarkers, Breast cancer high risk, Treadmill, Stationary bicycle, Questionnaires, Surveys, Motivational sessions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Groups:
If you agree to take part in this research study, you will be randomly assigned (as in a roll of dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to each group:
- If you are in Group 1, you will take part in high-intensity interval (HIIT) exercise.
- If you are in Group 2, you will take part in moderate-intensity exercise.
- If you are in Group 3, you will not take part in any assigned exercise, but you will receive written materials and counseling by an exercise physiologist.
If you are in Group 1 or Group 2, you will also receive written materials and instructions on how to perform your exercises.
Physical Activity:
If you are in Group 1 or 2, you will come to the Energy Balance Center to exercise 3 times a week for 12 weeks.
If you are in Group 1, you will walk uphill on a treadmill for a total of 33 minutes. There will be a 5-minute warm up, followed by four 4-minute intervals. Between each interval, you will walk for 3 minutes. There will be a 3 minute cool down.
If you are in Group 2, you will exercise at the Energy Balance Center 3 times a week. You will walk uphill on a treadmill or use a stationary bicycle continuously for 41 minutes.
If you are in Group 3, 1 time each month while you are on study, you will be called by a member of the study staff and asked about any exercise you have done and your weight loss goals. Each phone call should take about 15 minutes.
The exercise training intensity may be reduced or stopped temporarily if you experience side effects.
Length of Study:
No matter which group you are in, your participation in this study will be over after 12 weeks. You will be taken off study if you have intolerable side effects.
Study Visits:
All participants will visit the MD Anderson Behavioral Research and Treatment Center for each study visit.
At baseline:
- You will have a cardiopulmonary exercise test (CPET) to check your lung function. The CPET checks how well your lungs are working by measuring how much oxygen and carbon dioxide your lungs take in and release when you breathe. To perform this test, you will be asked to walk on a treadmill until you reach a point that you can no longer exercise. You will be breathing into the machine while you walk. This test will take about 30 minutes to complete. The study doctor will be present for each CPET and available to respond to any complication.
- You will have an EKG to check your heart function. The study doctor will be present for each EKG you have.
- Blood (about 1½ tablespoons) will be drawn for biomarker testing. You will be asked to fast (eat nothing and drink only water) for at least 12 hours before each blood draw as part of this study.
- You will have a dual-energy x-ray absorptiometry (DEXA) scan to measure your body mass.
- You will complete a questionnaire that will ask you about your demographics (age, race, and so on), past medical history, and lifestyle habits. This questionnaire should take about 5 minutes to complete.
- You will complete 5 questionnaires about your quality of life, exercise experience, and level of fatigue. These should take a total of about 15 minutes to complete.
At 6 weeks:
- You will have a CPET.
- You will have an EKG.
At 12 weeks:
- You will have a CPET.
- Blood (about 1½ tablespoons) will be drawn for biomarker testing.
- You will have an EKG.
- You will have a DEXA scan.
- You will complete the same questionnaires that you completed at baseline.
- If you are in Group 1 or 2, you will be interviewed by a member of the study staff. You will be asked 5 questions about your experience with your assigned exercise program. It should take about 5 minutes to complete.
One (1) time each month, you will attend a motivational session. During this session, you will discuss strategies for overcoming barriers that may be keeping you from attending or completing your exercises. You will also talk about continuing physical activity after you complete the program. This session should last about 15-30 minutes.
Additional Information:
- Trained health professionals will be present at all study visits to address any symptoms during exercise. If you feel that you are having difficulty breathing, experiencing dizziness, or are having any heart related symptoms while exercising at home, please stop exercising and call 911 immediately.
- Clinical information such as your name, patient medical record number, age, gender, body mass index (BMI), zip code, and your complete medical history will be collected from your medical record.
- If you are in Group 1 or Group 2, you will receive text messages before each exercise session to remind you to attend. You will be responsible for any text messaging charges. Standard text message rates will apply.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training (HIIT) Group | Experimental | Other: Exercise, Behavioral: Questionnaires, Behavioral: Motivational Session, Other: Printed MaterialsParticipants 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 | Experimental | Other: Exercise, Behavioral: Questionnaires, Behavioral: Motivational Session, Other: Printed MaterialsParticipants 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 comparator | Behavioral: Questionnaires, Behavioral: Motivational Session, Behavioral: Phone CallParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseHigh-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. | Other | High-Intensity Interval Training (HIIT) Group, Moderate-Intensity Continuous Training (MICT) Group |
| QuestionnairesAlso: SurveysParticipants 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. | Behavioural | Control Group, High-Intensity Interval Training (HIIT) Group, Moderate-Intensity Continuous Training (MICT) Group |
| Motivational SessionOne (1) time each month, participant attends a motivational session for 12 weeks. | Behavioural | Control Group, High-Intensity Interval Training (HIIT) Group, Moderate-Intensity Continuous Training (MICT) Group |
| Phone CallParticipants 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. | Behavioural | Control Group |
| Printed MaterialsHigh-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. | Other | High-Intensity Interval Training (HIIT) Group, Moderate-Intensity Continuous Training (MICT) Group |
Primary outcome
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%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Derived from this study: PubMed 33555464Coletta 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan C. Gilchrist, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Questionnaires and Motivational Session in people with Disorders of Breast, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of High-Intensity Interval Exercise to Offset the Tumor Promoting Effects of Obesity in High-Risk Breast Cancer Participants (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02923401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.