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

Primary Purpose

Overweight, Postmenopausal, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weight loss intervention
Weight Loss
Weight Loss
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight focused on measuring breast cancer survivor, weight loss, postmenopausal, Weight loss for overweight postmenopausal breast cancer survivors

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Vermont Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

weight loss intervention

Weight Loss plus Resistance Training

Comparator

Arm Description

Behavioral weight loss intervention

Behavioral weight loss intervention with the addition of resistance training

Group of women who did not receive chemotherapy

Outcomes

Primary Outcome Measures

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
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

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.
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.
Oral glusoe tolerence test
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.
Assess changes in health-related quality of life after a weight loss intervention.
Outcomes include SF-36 and FACT-fatigue surveys
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.

Full Information

First Posted
April 12, 2010
Last Updated
January 14, 2013
Sponsor
University of Vermont
Collaborators
University of Vermont Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01482702
Brief Title
Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors
Acronym
VCC0910
Official Title
Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
University of Vermont Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Postmenopausal, Breast Cancer
Keywords
breast cancer survivor, weight loss, postmenopausal, Weight loss for overweight postmenopausal breast cancer survivors

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
weight loss intervention
Arm Type
Experimental
Arm Description
Behavioral weight loss intervention
Arm Title
Weight Loss plus Resistance Training
Arm Type
Experimental
Arm Description
Behavioral weight loss intervention with the addition of resistance training
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Group of women who did not receive chemotherapy
Intervention Type
Behavioral
Intervention Name(s)
weight loss intervention
Intervention Description
Behavioral weight loss intervention
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss
Intervention Description
Behavioral weight loss intervention
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss
Intervention Description
Behavioral weight loss intervention
Primary Outcome Measure Information:
Title
Identify changes in energy balance and insulin sensitivity parameters in overweight breast cancer survivors after a behavioral weight loss intervention.
Description
Primary outcome measures include weight, fat free mass, fat mass, total and active energy expenditure, calorie intake and oral glucose tolence test
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.
Title
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.
Description
Outcomes include weight, fat free mass, fat mass, strength (upper extremity and lower extremity) and oral glucose tolerence test
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.
Secondary Outcome Measure Information:
Title
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.
Description
Outcomes: weight, fat mass, Fat free mass, total and active energy expenditure, calorie intake
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.
Title
Determine differences in insulin sensitivity parameters between post menopausal breast cancer survivors who received chemotherapy and those who did not.
Description
Oral glusoe tolerence test
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.
Title
Determine feasibility, acceptability, and safety of weight loss intervention without resistance training for breast cancer survivors.
Description
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
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.
Title
Assess changes in health-related quality of life after a weight loss intervention.
Description
Outcomes include SF-36 and FACT-fatigue surveys
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.
Title
Determine feasibility, acceptability, and safety of weight loss intervention with resistance training for breast cancer survivors.
Description
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
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim L Dittus, MD, PhD
Organizational Affiliation
University of Vermont/ Fletcher Allen Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29587682
Citation
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.
Results Reference
derived
Links:
URL
http://vermontcancer.org
Description
Vermont Cancer Center

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Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors

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