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出境医 / 临床实验 / BAriaTric Surgery After Breast Cancer Treatment (BATS)

BAriaTric Surgery After Breast Cancer Treatment (BATS)

Study Description
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.

Condition or disease Intervention/treatment Phase
Early-stage Breast Cancer Obesity Procedure: Bariatric Surgery with Sleeve Gastrectomy Behavioral: Lifestyle Intervention Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : February 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Sleeve Gastrectomy & Lifestyle Intervention Procedure: Bariatric Surgery with Sleeve Gastrectomy
Standard of care bariatric surgery with sleeve gastrectomy

Behavioral: Lifestyle Intervention
All participants receive lifestyle intervention. The lifestyle intervention program is modeled closely after that used in the Diabetes Primary Prevention Trial and the LookAHEAD diabetes treatment studies. Intervention includes counseling sessions weekly for the first six months, twice a month during months 7-9, and monthly during months 10-12, and energy intake and exercise goal monitoring and guidance.
Active Comparator: Lifestyle Intervention Behavioral: Lifestyle Intervention
All participants receive lifestyle intervention. The lifestyle intervention program is modeled closely after that used in the Diabetes Primary Prevention Trial and the LookAHEAD diabetes treatment studies. Intervention includes counseling sessions weekly for the first six months, twice a month during months 7-9, and monthly during months 10-12, and energy intake and exercise goal monitoring and guidance.
Outcome Measures
Primary Outcome Measures :
  1. Feasibility of Weight Loss Intervention [ Time Frame: 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.

  2. Acceptability of Weight Loss Intervention [ Time Frame: 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.


Secondary Outcome Measures :
  1. Weight Loss [ Time Frame: 1 Year ]
    Percent body mass weight loss

  2. Breast Cancer Recurrence [ Time Frame: 1 Year ]
    Incidence of breast cancer recurrence

  3. Cancer Related Mortality [ Time Frame: 1 Year ]
    Incidence of cancer related mortality

  4. Overall Mortality [ Time Frame: 1 Year ]
    Incidence of overall mortality


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sara Eischen 612-624-0902 bengt008@umn.edu

Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Layout table for investigator information
Principal Investigator: Anne Blaes, MD University of Minnesota, Division of Hematology, Oncology and Transplantation
Tracking Information
First Submitted Date  ICMJE May 8, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date September 30, 2020
Estimated Study Start Date  ICMJE May 2021
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • Feasibility of Weight Loss Intervention [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Feasibility of Weight Loss Intervention [ Time Frame: 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 Intervertion [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • Weight Loss [ Time Frame: 1 Year ]
    Percent body mass weight loss
  • Breast Cancer Recurrence [ Time Frame: 1 Year ]
    Incidence of breast cancer recurrence
  • Cancer Related Mortality [ Time Frame: 1 Year ]
    Incidence of cancer related mortality
  • Overall Mortality [ Time Frame: 1 Year ]
    Incidence of overall mortality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BAriaTric Surgery After Breast Cancer Treatment (BATS)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Early-stage Breast Cancer
  • Obesity
Intervention  ICMJE
  • Procedure: Bariatric Surgery with Sleeve Gastrectomy
    Standard of care bariatric surgery with sleeve gastrectomy
  • Behavioral: Lifestyle Intervention
    All participants receive lifestyle intervention. The lifestyle intervention program is modeled closely after that used in the Diabetes Primary Prevention Trial and the LookAHEAD diabetes treatment studies. Intervention includes counseling sessions weekly for the first six months, twice a month during months 7-9, and monthly during months 10-12, and energy intake and exercise goal monitoring and guidance.
Study Arms  ICMJE
  • Experimental: Sleeve Gastrectomy & Lifestyle Intervention
    Interventions:
    • Procedure: Bariatric Surgery with Sleeve Gastrectomy
    • Behavioral: Lifestyle Intervention
  • Active Comparator: Lifestyle Intervention
    Intervention: Behavioral: Lifestyle Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2023
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 67 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sara Eischen 612-624-0902 bengt008@umn.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03946423
Other Study ID Numbers  ICMJE 2018LS148
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne Blaes, MD University of Minnesota, Division of Hematology, Oncology and Transplantation
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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