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Search / Trial NCT03946423

BAriaTric Surgery After Breast Cancer Treatment (BATS)

Launched by MASONIC CANCER CENTER, UNIVERSITY OF MINNESOTA · May 8, 2019

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

ClinConnect Summary

The BAriaTric Surgery After Breast Cancer Treatment (BATS) trial is exploring whether women who have had early-stage breast cancer and are currently dealing with obesity would be willing to join a weight-loss study. This study aims to understand how many women are interested in participating, whether they would accept a specific treatment (like weight-loss surgery along with lifestyle changes or just lifestyle changes), and if they can follow the study guidelines for a year. If this initial study goes well, the findings will help design a larger trial to see how losing weight might affect the chance of cancer coming back.

To be eligible for this study, women need to have been diagnosed with breast cancer in the last 10 years and be currently cancer-free. They should also have completed their cancer treatments at least six months before joining the study and have a body mass index (BMI) between 35 and 50, which indicates obesity. Participants must be between 18 and 67 years old, generally healthy enough for surgery, and willing to accept being assigned to either treatment group. Women interested in taking part will need to provide written consent and have insurance that covers obesity-related treatments. This study is not yet recruiting participants, but it offers a chance for eligible women to potentially improve their health while contributing to important research on breast cancer and obesity.

Gender

FEMALE

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.

About Masonic Cancer Center, University Of Minnesota

The Masonic Cancer Center at the University of Minnesota is a leading institution dedicated to cancer research, treatment, and prevention. As a National Cancer Institute-designated Comprehensive Cancer Center, it integrates innovative research with clinical practice to enhance patient care and advance medical knowledge. The center fosters collaboration among scientists, clinicians, and educators, focusing on multidisciplinary approaches to tackle the complexities of cancer. Through its commitment to cutting-edge clinical trials, the Masonic Cancer Center aims to translate scientific discoveries into effective therapies, ultimately improving outcomes for cancer patients locally and globally.

Locations

Patients applied

0 patients applied

Trial Officials

Anne Blaes, MD

Principal Investigator

University of Minnesota, Division of Hematology, Oncology and Transplantation

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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