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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 主要终点
- Feasibility of Weight Loss Intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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/m
- •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/m
- •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.
排除标准
- •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.
研究组 & 干预措施
Sleeve Gastrectomy & Lifestyle Intervention
干预措施: Bariatric Surgery with Sleeve Gastrectomy (Procedure)
Sleeve Gastrectomy & Lifestyle Intervention
干预措施: Lifestyle Intervention (Behavioral)
Lifestyle Intervention
干预措施: Lifestyle Intervention (Behavioral)
结局指标
主要结局
Feasibility of Weight Loss Intervention
时间窗: 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
时间窗: 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.
次要结局
- Weight Loss(1 Year)
- Breast Cancer Recurrence(1 Year)
- Cancer Related Mortality(1 Year)
- Overall Mortality(1 Year)