Physical Activity or Usual Care in Preventing Weight Gain in Women With Stage I or Stage II Breast Cancer Undergoing Chemotherapy

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer, Depression, Fatigue, Psychosocial Effects of Cancer and Its Treatment, Weight Changes

In brief

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.

Key facts

Study ID

NCT00509626

Run by

Fox Chase Cancer Center

People needed

380

Starts

2007-06-01

Last updated by the study team

2010-02-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fox Chase Cancer Center - Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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