NCT01482702

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

2.3 years

First QC Date

April 12, 2010

Last Update Submit

January 14, 2013

Conditions

OverweightPostmenopausalBreast Cancer

Keywords

breast cancer survivorweight losspostmenopausalWeight loss for overweight postmenopausal breast cancer survivors

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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 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.

    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.

    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.

    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.

    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.

Study Arms (3)

weight loss intervention

EXPERIMENTAL

Behavioral weight loss intervention

Behavioral: weight loss intervention

Weight Loss plus Resistance Training

EXPERIMENTAL

Behavioral weight loss intervention with the addition of resistance training

Behavioral: Weight Loss

Comparator

ACTIVE COMPARATOR

Group of women who did not receive chemotherapy

Behavioral: Weight Loss

Interventions

weight loss interventionBEHAVIORAL

Behavioral weight loss intervention

weight loss intervention
Weight LossBEHAVIORAL

Behavioral weight loss intervention

Weight Loss plus Resistance Training

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vermont Cancer Center

Burlington, Vermont, 05405, United States

Location

Related Publications (1)

  • 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.

    PMID: 29587682DERIVED

Related Links

MeSH Terms

Conditions

OverweightBreast NeoplasmsWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBody Weight Changes

Study Officials

  • Kim L Dittus, MD, PhD

    University of Vermont/ Fletcher Allen Health Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Assistant Professor

Study Record Dates

First Submitted

April 12, 2010

First Posted

November 30, 2011

Study Start

October 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

US(1)