Health TrialsbyHealthPanel

BAriaTric Surgery After Breast Cancer Treatment (BATS)

ConditionsEarly-stage Breast CancerObesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-67
SponsorMasonic Cancer Center, University of Minnesota

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bariatric Surgery with Sleeve Gastrectomy

    Procedure/Surgery

    Standard of care bariatric surgery with sleeve gastrectomy

  • Lifestyle Intervention

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Sleeve Gastrectomy & Lifestyle InterventionExperimental treatment 2 interventions
Group B: Lifestyle InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Weight Loss Intervention

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.

Time frame
1 Year
2

Acceptability of Weight Loss Intervention

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.

Time frame
1 Year

Secondary outcomes

1

Weight Loss

Percent body mass weight loss

Time frame
1 Year
2

Breast Cancer Recurrence

Incidence of breast cancer recurrence

Time frame
1 Year
3

Cancer Related Mortality

Incidence of cancer related mortality

Time frame
1 Year
4

Overall Mortality

Incidence of overall mortality

Time frame
1 Year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masonic Cancer Center, University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: