BAriaTric Surgery After Breast Cancer Treatment (BATS) (NCT03946423) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
BAriaTric Surgery After Breast Cancer Treatment (BATS)
40 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range18 Years – 67 Years
SexFEMALE
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Inclusion Criteria:
* 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
* Deemed healthy enough to undergo bariatric surgery, if assigned intervention, as determined by a surgeon and documented in the medical record.
* Must have insurance coverage with no exclusion for obesity related treatment or management of obesity related surgical complications - in general insurance coverage is available for persons with a BMI ≥ 35 kg/m2.
* Anticipated ability to abide by study requirements demonstrated in part by, but not limited to, successful completion of run-in assessments.
* Willingness to accept randomization into either interventional group.
* Provides voluntary written consent prior to performance of any research related activities.
Exclusion Criteria:
* 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.
* Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy.
* History of st…
What they're measuring
1
Feasibility of Weight Loss Intervention
Timeframe: 1 Year
2
Acceptability of Weight Loss Intervention
Timeframe: 1 Year
Trial details
NCT IDNCT03946423
SponsorMasonic Cancer Center, University of Minnesota