BAriaTric Surgery After Breast Cancer Treatment (BATS)

This is an interventional other trial for Early-stage Breast Cancer Read More

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.