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Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors

40 Years
65 Years
Not Enrolling
Overweight, Postmenopausal, Breast Cancer

Thank you

Trial Information

Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors

Inclusion Criteria:

- Post-menopausal (last period 12 mos prior to study enrollment or oophorectomy)

- Age 40-65

- DCIS, Stage I, II, III Breast Cancer

- BMI between 27-50

- Completed chemotherapy to treat early stage breast cancer (Stage I-III) no less then
6 months and no more than 48 months from start of study or for specific aim 3
Diagnosis of DCIS or Stage I breast cancer who did not receive chemotherapy.

Exclusion Criteria:

- Participant can not have a psychotic or central nervous system impairment that would
limit compliance with study requirements

- Evidence of metastatic disease

- Chemotherapy for cancer other than breast cancer

- Diabetes mellitus, uncontrolled hypo or hyper thyroidism, liver failure

- Celiac sprue, inflammatory bowel disease

- Inability to walk for exercise

- Lymphedema as indicated by a 2 cm circumference difference at the elbow

- weight loss in the previous 6 months of 10 lbs or greater

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Identify changes in energy balance and insulin sensitivity parameters in overweight breast cancer survivors after a behavioral weight loss intervention.

Outcome Description:

Primary outcome measures include weight, fat free mass, fat mass, total and active energy expenditure, calorie intake and oral glucose tolence test

Outcome Time Frame:

Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.

Safety Issue:


Principal Investigator

Kim L Dittus, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Vermont/ Fletcher Allen Health Care


United States: Institutional Review Board

Study ID:




Start Date:

October 2009

Completion Date:

January 2012

Related Keywords:

  • Overweight
  • Postmenopausal
  • Breast Cancer
  • breast cancer survivor
  • weight loss
  • postmenopausal
  • Weight loss for overweight postmenopausal breast cancer survivors
  • Breast Neoplasms
  • Weight Loss
  • Overweight



Vermont Cancer CenterBurlington, Vermont  05401-3498