Clinical trial NCT03946423: BAriaTric Surgery After Breast Cancer Treatment (BATS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Early-stage Breast Cancer
Obesity
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Feasibility of Weight Loss Intervention
timeFrame: 1 Year
measure: Acceptability of Weight Loss Intervention
timeFrame: 1 Year
Secondary outcomes:
measure: Weight Loss
timeFrame: 1 Year
measure: Breast Cancer Recurrence
timeFrame: 1 Year
measure: Cancer Related Mortality
timeFrame: 1 Year
measure: Overall Mortality
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota, Division of Hematology, Oncology and Transplantation
name: Anne Blaes, MD
role: PRINCIPAL_INVESTIGATOR
References: