BAriaTric Surgery After Breast Cancer Treatment (BATS)

Not Applicable

Not yet recruiting

• Conditions: Obesity; Early-stage Breast Cancer
• Interventions: Procedure: Bariatric Surgery with Sleeve Gastrectomy; Behavioral: Lifestyle Intervention

• Registration Number: NCT03946423
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Study Start: 2025-06
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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.
• History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
• Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
• Deemed not an acceptable candidate by a trained psychologist.
• Current participation in a conflicting research protocol.
• Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
• Gastroesophageal reflux disease requiring medications. History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus.
• Any history of dysphagia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleeve Gastrectomy & Lifestyle Intervention	Bariatric Surgery with Sleeve Gastrectomy	-
Sleeve Gastrectomy & Lifestyle Intervention	Lifestyle Intervention	-
Lifestyle Intervention	Lifestyle Intervention	-

Primary Outcome Measures

Name	Time	Method
Feasibility of Weight Loss Intervention	1 Year	Feasibility for women who were diagnosed with early stage breast cancer in the previous 10 years and have a body mass index (BMI) of ≥ 35 kg/m2 but \< 50 kg/m2.
Acceptability of Weight Loss Intervention	1 Year	Acceptability of women who were diagnosed with early stage breast cancer in the previous 10 years and have a body mass index (BMI) of ≥ 35 kg/m2 but \< 50 kg/m2.

Secondary Outcome Measures

Name	Time	Method
Weight Loss	1 Year	Percent body mass weight loss
Breast Cancer Recurrence	1 Year	Incidence of breast cancer recurrence
Cancer Related Mortality	1 Year	Incidence of cancer related mortality
Overall Mortality	1 Year	Incidence of overall mortality