NCT03946423

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early-stage Breast Cancer
• Obesity

Interventions

Type	Name	Description
PROCEDURE	Bariatric Surgery with Sleeve Gastrectomy	Standard of care bariatric surgery with sleeve gastrectomy
BEHAVIORAL	Lifestyle Intervention	All participants receive lifestyle intervention. The lifestyle intervention program is modeled closely after that used in the Diabetes Primary Prevention Trial and the LookAHEAD diabetes treatment studies. Intervention includes counseling sessions weekly for the first six months, twice a month during months 7-9, and monthly during months 10-12, and energy intake and exercise goal monitoring and guidance.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2019-05-10
• Last updated: 2025-07-24