BAriaTric Surgery After Breast Cancer Treatment (BATS)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-67
SponsorMasonic Cancer Center, University of Minnesota
About this trial
This is a feasibility study to gain an understanding of the willingness of women with a history of early stage breast cancer and current obesity to enroll in a weight-loss study, accept an assigned intervention (bariatric surgery with lifestyle intervention or lifestyle intervention alone), and comply with the study plan for 1 year. If there is successful enrollment in this study, the plan is to use what is learned in this study to design a larger, longer-term clinical trial to look at the effect of weight loss and incidence of cancer recurrence.
Eligibility criteria
Qualifiers
Diagnosis of breast cancer in the previous 10 years and currently disease free.
Completion of breast cancer treatment (radiation, chemotherapy) at least > 6 months prior to enrollment
Body mass index (BMI) of ≥ 35 kg/m2, but < 50 kg/m2.
18 through 67 years of age at enrollment
Disqualifiers
Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
Cardiac stress test indicating that surgery or lifestyle would not be safe.
12-lead EKG indicating that surgery would not be safe.
Trial design
Treatments tested in this trial
- Bariatric Surgery with Sleeve Gastrectomy
- Lifestyle Intervention
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov