BAriaTric Surgery After Breast Cancer Treatment (BATS)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Early-stage Breast Cancer, Obesity

Intervention / Treatment
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* Procedure: Bariatric Surgery with Sleeve Gastrectomy
* Behavioral: Lifestyle Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleeve Gastrectomy & Lifestyle Intervention<br> | Procedure: Bariatric Surgery with Sleeve Gastrectomy<br>* Standard of care bariatric surgery with sleeve gastrectomy<br>Behavioral: Lifestyle Intervention<br>* 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.<br>|
| Active Comparator: Lifestyle Intervention<br> | Behavioral: Lifestyle Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Percent body mass weight loss | 1 Year | 
| Breast Cancer Recurrence | Incidence of breast cancer recurrence | 1 Year | 
| Cancer Related Mortality | Incidence of cancer related mortality | 1 Year | 
| Overall Mortality | Incidence of overall mortality | 1 Year |