MedTrace Logo

BAriaTric Surgery After Breast Cancer Treatment (BATS)

NCT03946423 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Anne Blaes, MD · University of Minnesota, Division of Hematology, Oncology and Transplantation

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-02-28
Completion
2028-02-29

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03946423 on ClinicalTrials.gov