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Weight Gain Prevention Program for Breast Cancer

N/A
Waitlist Available
Led By Karen Basen-Engquist, PhD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six assessments: baseline, 3 months after starting chemotherapy, at the end of chemotherapy, after recovery from surgery, at the end of the 9-week booster intervention, and 6 months after surgery.
Awards & highlights

Study Summary

The specific aims of this study are: To test the feasibility of a randomized controlled trial of a weight gain prevention program for breast cancer survivors that combines exercise and dietary changes during treatment. Feasibility will be evaluated by examining data on recruitment rate, attendance at intervention sessions, drop-out rates in both study conditions, assessment completion rates, and participant feedback. To test the effect of a weight gain prevention program, compared to usual care, on weight, body composition, and biomarkers related to breast cancer prognosis. To explore whether changes in physical activity, energy intake, and resting energy expenditure predict weight gain among breast cancer survivors. To test the effect of a weight gain prevention program on quality of life variables.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six assessments: baseline, 3 months after starting chemotherapy, at the end of chemotherapy, after recovery from surgery, at the end of the 9-week booster intervention, and 6 months after surgery.
This trial's timeline: 3 weeks for screening, Varies for treatment, and six assessments: baseline, 3 months after starting chemotherapy, at the end of chemotherapy, after recovery from surgery, at the end of the 9-week booster intervention, and 6 months after surgery. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight or Percentage (%) Body Fat

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Weight Gain Prevention ProgramExperimental Treatment2 Interventions
Intervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling. Packet of questionnaires will be completed.
Group II: Standard Care GroupActive Control1 Intervention
Packet of questionnaires will be completed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaire
2014
Completed Phase 2
~20090

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,756 Total Patients Enrolled
147 Trials studying Breast Cancer
63,240 Patients Enrolled for Breast Cancer
Lance Armstrong FoundationOTHER
9 Previous Clinical Trials
1,005 Total Patients Enrolled
Karen Basen-Engquist, PhDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
2,565 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Weight Gain Prevention for Breast Cancer Survivors
2007. "Weight Gain Prevention for Breast Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00533338.
All > Weight Gain > Breast
~3 spots leftby Apr 2025
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