bariatric surgery after breast cancer treatment (bats)

Conditions: Early-stage Breast Cancer; Obesity

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.


Eligibility criteria:
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.