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Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors


N/A
40 Years
65 Years
Not Enrolling
Female
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:

Interventional

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:

No

Principal Investigator

Kim L Dittus, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Vermont/ Fletcher Allen Health Care

Authority:

United States: Institutional Review Board

Study ID:

10-031

NCT ID:

NCT01482702

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

Name

Location
Vermont Cancer Center Burlington, Vermont  05401-3498