Clinical trial · Interventional
Weight Gain Prevention for Breast Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire | Behavioral | — | UNRESOLVED |
| Weight Gain Prevention Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Weight Gain Prevention Program
- description
- Intervention program including in-person instruction and counseling about exercise and diet, exercise practice sessions, and telephone counseling. Packet of questionnaires will be completed.
- interventionNames
- Behavioral: Weight Gain Prevention Program
- Behavioral: Questionnaire
- type
- ACTIVE_COMPARATOR
- label
- Standard Care Group
- description
- Packet of questionnaires will be completed.
- interventionNames
- Behavioral: Questionnaire
Primary outcomes (1)
- measure
- Weight or Percentage (%) Body Fat
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Woman with newly diagnosed stage II or III breast cancer. 2. Over 18 years of age. 3. Beginning neo-adjuvant chemotherapy at M. D. Anderson (no more than 3 weeks from the administration of the first cycle). 4. Speaks and reads English. 5. Oriented to person, place, and time. 6. Able to come to M. D. Anderson once a week for intervention. 7. Has physician clearance to engage in moderate physical activity. 8. Lives in Harris County, Texas or a county contiguous to Harris County, Texas. Exclusion Criteria: 1. Have any of the following conditions defined by the American College of Sports Medicine as absolute contraindications to exercise testing (a recent significant change in the resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 days) or acute cardiac event; unstable angina; uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise; severe symptomatic aortic stenosis; uncontrolled symptomatic heart failure; acute pulmonary embolus or pulmonary infarction; acute myocarditis or pericarditis; suspected or known dissecting aneurysm; acute infection). 2. Have any of the following conditions as defined by the American College of Sports Medicine as relative contraindications to exercise testing (left main coronary stenosis; moderate stenotic valvular heart disease; electrolyte abnormalities; severe arterial hypertension at rest; hypertrophic cardiomyopathy and other forms of outflow tract obstruction; neuromuscular, musculoskeletal, or rheumatoid disorders that are exacerbated by exercise; high-degree atrioventricular block; ventricular aneurysm; uncontrolled metabolic disease; chronic infectious disease). 3. Right or left bundle branch block. 4. Baseline ST segment or T wave changes that would make monitoring of the ECG stress test indeterminate. 5. Uncontrolled asthma. 6. Have other medical contraindications as defined by the patient's physician. 7. Have inflammatory breast cancer.
References
Publications (1)
- DERIVEDBasen-Engquist KM, Raber M, Carmack CL, Arun B, Brewster AM, Fingeret M, Schembre SM, Harrison C, Perkins HY, Li Y, Song J, Chen M, Murray JL. Feasibility and efficacy of a weight gain prevention intervention for breast cancer patients receiving neoadjuvant chemotherapy: a randomized controlled pilot study. Support Care Cancer. 2020 Dec;28(12):5821-5832. doi: 10.1007/s00520-020-05411-2. Epub 2020 Apr 5. PMID 32249355