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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 up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

The specific aims of this study are: 1. 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. 2. 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. 3. To explore whether changes in physical activity, energy intake, and resting energy expenditure predict weight gain among breast cancer survivors. 4. 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 ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~19970

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,062 Previous Clinical Trials
1,800,705 Total Patients Enrolled
146 Trials studying Breast Cancer
63,027 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
~3 spots leftby Nov 2025
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