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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Overweight; Postmenopausal
• Intervention / Treatment: Behavioral: weight loss intervention; Behavioral: Weight Loss

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • Vermont Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify changes in energy balance and insulin sensitivity parameters in overweight breast cancer survivors after a behavioral weight loss intervention.	Primary outcome measures include weight, fat free mass, fat mass, total and active energy expenditure, calorie intake and oral glucose tolence test	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.
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.	Outcomes include weight, fat free mass, fat mass, strength (upper extremity and lower extremity) and oral glucose tolerence test	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Outcomes: weight, fat mass, Fat free mass, total and active energy expenditure, calorie intake	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.
Determine differences in insulin sensitivity parameters between post menopausal breast cancer survivors who received chemotherapy and those who did not.	Oral glusoe tolerence test	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.
Determine feasibility, acceptability, and safety of weight loss intervention without resistance training for breast cancer survivors.	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.	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.
Assess changes in health-related quality of life after a weight loss intervention.	Outcomes include SF-36 and FACT-fatigue surveys	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.
Determine feasibility, acceptability, and safety of weight loss intervention with resistance training for breast cancer survivors.	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.	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.

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: University of Vermont Medical Center
• Investigators: Principal Investigator: Kim L Dittus, MD, PhD, University of Vermont/ Fletcher Allen Health Care

Publications and helpful links

General Publications

• Dittus KL, Harvey JR, Bunn JY, Kokinda ND, Wilson KM, Priest J, Pratley RE. Impact of a behaviorally-based weight loss intervention on parameters of insulin resistance in breast cancer survivors. BMC Cancer. 2018 Mar 27;18(1):351. doi: 10.1186/s12885-018-4272-2.

Helpful Links

• Vermont Cancer Center

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (Estimate): November 30, 2011

Study Record Updates

• Last Update Posted (Estimate): January 15, 2013
• Last Update Submitted That Met QC Criteria: January 14, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: weight loss; postmenopausal; breast cancer survivor; Weight loss for overweight postmenopausal breast cancer survivors
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Body Weight; Body Weight Changes; Breast Neoplasms; Weight Loss; Overweight
• Other Study ID Numbers: 10-031