BAriaTric Surgery After Breast Cancer Treatment (BATS)

NCT03946423 | Withdrawn

• 1 other identifier: 2018LS148
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Early-stage Breast Cancer; Obesity

Outcome Measures

Primary Outcomes (2)

• Feasibility of Weight Loss Intervention

  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.

  1 Year

• Acceptability of Weight Loss Intervention

  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.

  1 Year

Secondary Outcomes (4)

• Weight Loss

  1 Year

• Breast Cancer Recurrence

  1 Year

• Cancer Related Mortality

  1 Year

• Overall Mortality

  1 Year

Study Arms (2)

Sleeve Gastrectomy & Lifestyle Intervention

EXPERIMENTAL

Procedure: Bariatric Surgery with Sleeve Gastrectomy; Behavioral: Lifestyle Intervention

Lifestyle Intervention

ACTIVE COMPARATOR

Behavioral: Lifestyle Intervention

Interventions

Bariatric Surgery with Sleeve Gastrectomy PROCEDURE

Standard of care bariatric surgery with sleeve gastrectomy

Sleeve Gastrectomy & Lifestyle Intervention

Lifestyle Intervention BEHAVIORAL

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.

Lifestyle Intervention; Sleeve Gastrectomy & Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

MeSH Terms

Conditions

Breast Neoplasms; Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Anne Blaes, MD

  University of Minnesota, Division of Hematology, Oncology and Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07