Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors (VCC0910)

This study has been completed.
Sponsor:
Collaborator:
Fletcher Allen Health Care
Information provided by (Responsible Party):
Kim Dittus, University of Vermont
ClinicalTrials.gov Identifier:
NCT01482702
First received: April 12, 2010
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

Obesity is an epidemic and the majority of breast cancer survivors are overweight or obese. The American Cancer Society has called for weight loss treatment to be standard of care for overweight women with breast cancer. During therapy women with breast cancer often gain weight and lose lean muscle mass. Overweight breast cancer survivors are more likely to have their cancer come back. The reason why overweight breast cancer survivors are more likely to re-occur has not been well studied, but changes in how insulin works may contribute. Overweight survivors are also at risk for the other chronic diseases associated with obesity. Fortunately, weight losses of as little as 5-7% of baseline body weight can improve risk of chronic disease. An effective behaviorally-based, lifestyle intervention delivered via the internet has been developed at the University of Vermont. This successful intervention has not been tested among breast cancer survivors. Given that women tend to lose muscle mass during cancer therapy the addition of a resistance training component to the weight loss intervention may be important. Therefore the overall goal of this project is to pilot test a proven distantly- delivered behavioral weight loss intervention among overweight breast cancer survivors and to evaluate whether a resistance program results in improvements in lean body mass, while studying how both interventions change insulin sensitivity.

Specifically, this project is a randomized, controlled clinical trial designed to test the effectiveness and acceptability of a 6-month behavioral weight loss intervention with and without resistance training. Participants will be randomized to one of two groups: 1) behavioral weight control treatment via the Internet; or 2) behavioral weight control treatment via the Internet plus a resistance training program. Women eligible to participate include overweight breast cancer survivors who are age 50 or older and 6-36 months past receiving chemotherapy. Assessments will be conducted at baseline and six months and will include measures of body weight, muscle mass, adherence to treatment, and insulin sensitivity.


Condition Intervention
Overweight
Postmenopausal
Breast Cancer
Behavioral: weight loss intervention
Behavioral: Weight Loss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Identify changes in energy balance and insulin sensitivity parameters in overweight breast cancer survivors after a behavioral weight loss intervention. [ 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. ] [ Designated as safety issue: No ]
    Primary outcome measures include weight, fat free mass, fat mass, total and active energy expenditure, calorie intake and oral glucose tolence test

  • Determine whether the addition of resistance training to a behavioral weight loss intervention preserves muscle mass and improves weight loss or insulin sensitivity in breast cancer survivors. [ 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. ] [ Designated as safety issue: No ]
    Outcomes include weight, fat free mass, fat mass, strength (upper extremity and lower extremity) and oral glucose tolerence test


Secondary Outcome Measures:
  • Identify differences in weight loss and energy balance between post menopausal breast cancer survivors who received chemotherapy and those who did not receive chemotherapy as part of their oncologic management. [ 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. ] [ Designated as safety issue: No ]
    Outcomes: weight, fat mass, Fat free mass, total and active energy expenditure, calorie intake

  • Determine differences in insulin sensitivity parameters between post menopausal breast cancer survivors who received chemotherapy and those who did not. [ 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. ] [ Designated as safety issue: No ]
    Oral glusoe tolerence test

  • Determine feasibility, acceptability, and safety of weight loss intervention without resistance training for breast cancer survivors. [ 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. ] [ Designated as safety issue: No ]
    Outcomes include compliance as determined by percent of indiviudals completing each lesson and completing the program. Saftery is assessed by identifying injury or worsening lymphedema. Acceptability is determined with a survey.

  • Assess changes in health-related quality of life after a weight loss intervention. [ 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. ] [ Designated as safety issue: No ]
    Outcomes include SF-36 and FACT-fatigue surveys

  • Determine feasibility, acceptability, and safety of weight loss intervention with resistance training for breast cancer survivors. [ 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. ] [ Designated as safety issue: No ]
    Outcomes include compliance as determined by percent of indiviudals completing each lesson and completing the program. Saftery is assessed by identifying injury or worsening lymphedema. Acceptability is determined with a survey.


Enrollment: 72
Study Start Date: October 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: weight loss intervention
Behavioral weight loss intervention
Behavioral: weight loss intervention
Behavioral weight loss intervention
Experimental: Weight Loss plus Resistance Training
Behavioral weight loss intervention with the addition of resistance training
Behavioral: Weight Loss
Behavioral weight loss intervention
Active Comparator: Comparator
Group of women who did not receive chemotherapy
Behavioral: Weight Loss
Behavioral weight loss intervention

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482702

Locations
United States, Vermont
Vermont Cancer Center
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
Fletcher Allen Health Care
Investigators
Principal Investigator: Kim L Dittus, MD, PhD University of Vermont/ Fletcher Allen Health Care
  More Information

Additional Information:
No publications provided

Responsible Party: Kim Dittus, MD, PhD, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT01482702     History of Changes
Other Study ID Numbers: 10-031
Study First Received: April 12, 2010
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
breast cancer survivor
weight loss
postmenopausal
Weight loss for overweight postmenopausal breast cancer survivors

Additional relevant MeSH terms:
Breast Neoplasms
Weight Loss
Overweight
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014