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

April 12, 2010
January 14, 2013
October 2009
January 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01482702 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors
Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Overweight
  • Postmenopausal
  • Breast Cancer
  • Behavioral: weight loss intervention
    Behavioral weight loss intervention
  • Behavioral: Weight Loss
    Behavioral weight loss intervention
  • Experimental: weight loss intervention
    Behavioral weight loss intervention
    Intervention: Behavioral: weight loss intervention
  • Experimental: Weight Loss plus Resistance Training
    Behavioral weight loss intervention with the addition of resistance training
    Intervention: Behavioral: Weight Loss
  • Active Comparator: Comparator
    Group of women who did not receive chemotherapy
    Intervention: Behavioral: Weight Loss
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Female
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01482702
10-031
No
Kim Dittus, University of Vermont
University of Vermont
Fletcher Allen Health Care
Principal Investigator: Kim L Dittus, MD, PhD University of Vermont/ Fletcher Allen Health Care
University of Vermont
January 2013

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