Clinical trial · Interventional
Physical Activity or Usual Care in Preventing Weight Gain in Women With Stage I or Stage II Breast Cancer Undergoing Chemotherapy
A Physical Activity Intervention to Prevent Weight Gain in Breast Cancer Patients
NCT00509626CI-TRIAL-00003146completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Physical activity may prevent or reduce weight gain in women receiving chemotherapy for early stage breast cancer. PURPOSE: This randomized phase I/II trial is studying physical activity to see how well it works compared with usual care to prevent or reduce weight gain in women with stage I or stage II breast cancer undergoing chemotherapy.
Conditions
Conditions (5)
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 |
| Depression | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
| Weight Changes | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAM exercise therapy | Procedure | — | UNRESOLVED |
| exercise intervention | Behavioral | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Accrual (phase I)
- measure
- Retention (phase I)
- measure
- Weight change after 6 months (phase II)
Secondary outcomes (3)
- measure
- Adiposity as measured by waist circumference at 3 and 6 months
- measure
- Health-related quality of life as measured by the Short-Form Health Survey-12 Physical and Mental Component Summary scales
- measure
- Depressive symptomology as measured by the Center for Epidemiologic Studies Depression Scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Diagnosis of primary breast cancer * Newly diagnosed stage I or II disease * Receiving care at a participating Fox Chase Cancer Center CCOP Research Base (FCRB) member site * Geisinger Clinic and Medical Center (phase I) * Main Line Health (phase I) * Any of the other participating FCRB member sites (phase II) * Study intervention is scheduled to begin anytime after surgery up to 3 months after completion of adjuvant chemotherapy * Treatment plan includes adjuvant chemotherapy * Hormone receptor status not specified Exclusion criteria: * Treatment plan includes trastuzumab (Herceptin®) or bevacizumab * Recurrent breast cancer PATIENT CHARACTERISTICS: Inclusion criteria: * Female * Premenopausal or postmenopausal * Has obtained medical clearance by oncologist and breast surgeon to participate in this study * Body mass index ≥ 20 kg/m\^2 and \< 39 kg/m\^2 Exclusion criteria: * Hemoglobin \< 12 g/dL * ANC \< 1,500/mm\^3 * Any medical condition that restricts participation in a physical activity program (e.g., exercise-induced angina, uncontrolled hypertension, dementia, or a major psychological problem) * Answers "yes" to any questions on the Physical Activity Readiness Questionnaire (PAR-Q) and PAR-Q not reviewed by a physician who subsequently approves participation in the physical activity intervention * Known to be pregnant or breastfeeding * Unwilling to commit or unable to participate in a 6-month physical activity intervention (unable to exercise, usually travels away from home overnight more than once per week, and/or has plans to be away from home for more than two weeks in the next 6 months) * Previously diagnosed with another primary cancer other than basal cell or squamous cell carcinoma of the skin * Exercising regularly prior to intervention (i.e., reports current participation in vigorous or moderate activity at least 3 days per week for at least 30 minutes each day on the International Physical Activity Questionnaire) * Unable to speak and read English PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No neoadjuvant chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.