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BAriaTric Surgery After Breast Cancer Treatment (BATS) | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

BAriaTric Surgery After Breast Cancer Treatment (BATS)

BAriaTric Surgery After Breast Cancer Treatment (BATS) - A Randomized Trial of Sleeve Gastrectomy Versus Lifestyle Intervention in Women Diagnosed With Early Stage Breast and With a BMI of ≥ 35

NCT03946423•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 67 years

Sex

FEMALE

Healthy Volunteers

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 stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.
•Gastric or duodenal ulcer in the past six months.
•History of intra-abdominal sepsis except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment.
•Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
•Currently pregnant or nursing, or planning to become pregnant in the next 15 months.
+7 more criteria

Key Dates

Start Date

June 1, 2026

Primary Completion Date

February 1, 2027

Completion Date

February 1, 2028

Last Updated

July 24, 2025

Enrollment

ESTIMATED participants

Conditions

Early-stage Breast CancerObesity

Interventions

Bariatric Surgery with Sleeve Gastrectomy

PROCEDURE

Lifestyle Intervention

BEHAVIORAL

Contacts

Sara Eischen

CONTACT

612-624-0902 bengt008@umn.edu

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RECRUITINGNA

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BAriaTric Surgery After Breast Cancer Treatment (BATS)

Inclusion Criteria

Exclusion Criteria

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