A Study to Evaluate The Effect of Diet and Exercise on Biomarkers Associated with Obesity and Breast Cancer in Overweight Women with Early Stage Breast Cancer
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-008163
Sponsor Protocol Number: 18-008163
About this study
The primary purpose of this study is to investigate the relationship between a technology-assisted diet and exercise program which is easily implemented in an outpatient setting and the levels of biomarkers that have been associated with breast cancer recurrence risk in overweight women with stage 0, I, or II breast cancer.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Stage 0, I or II breast cancer within the last 5 years.
- BMI ≥ 25.
- Access to an electronic device with the capacity to support the FitBit and HealthWatch 360 apps, and an email address for feedback.
Exclusion Criteria:
- Unable to complete physical activity due to known medical illness (e.g., COPD, CAD, orthopedic injury).
- Currently, has an implantable electronic device or will be receiving one in the future.
- Any condition or disease or circumstance that in the Investigator’s opinion would put the patient at undue risk, prevent completion of the study, or interfere with the analysis of the trial results.
Eligibility last updated 11/15/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Aparna Kaur, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available