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

Sponsor

Fox Chase Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00509626

Collaborator

National Cancer Institute (NCI) (NIH)

380

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Depression Fatigue Psychosocial Effects of Cancer and Its Treatment Weight Changes	Behavioral: exercise intervention Other: questionnaire administration Procedure: CAM exercise therapy Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment	Phase 1/Phase 2

Detailed Description

OBJECTIVES:

Primary

Determine the feasibility for conducting a clinical trial that uses a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer and prior to initiation of adjuvant chemotherapy, hormonal therapy, and/or radiotherapy. (phase I)
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases weight gain in patients treated with adjuvant chemotherapy. (phase II)
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects weight change in women who are premenopausal compared to those who are postmenopausal at diagnosis. (phase II)

Secondary

Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases gains in adiposity in patients treated with adjuvant chemotherapy. (phase II)
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer differentially affects change in adiposity among women who are premenopausal compared to those who are postmenopausal at diagnosis. (phase II)
Determine if participation in a 6-month physical activity intervention initiated within 45 days after surgery for early-stage breast cancer decreases the frequency of depressive symptomology and improves quality of life among patients treated with adjuvant chemotherapy. (phase II)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating site and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 intervention arms.

Arm I (exercise and usual care): Patients receive usual care and are enrolled in an exercise and weight control program at Curves® fitness center. The Curves® program, which begins during the third week of study, uses aerobic activity and resistance training to reduce weight and increase strength and fitness. Patients exercise a minimum of 3 times per week, approximately 30 minutes every time, for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients' physical activity is measured at baseline and at the 3- and 6-month follow-up visits.

Patients also undergo behavior modification counseling with a study nurse to help them overcome the specific barriers to adhering to the recommended exercise routine. Counseling sessions are conducted every 2 to 3 weeks during chemotherapy and at least monthly after completion of chemotherapy for up to 6 months, starting within 2 weeks after randomization and prior to initiation of the Curves® intervention.

Arm II (control: usual care alone): Patients receive usual care and general advice on coping with their breast cancer treatment for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients receive no counseling or recommendations concerning emotional and practical barriers encountered during breast cancer treatment.

Dietary information is obtained from patients by telephone during three 24-hour dietary recalls performed within 2 weeks of baseline and at the 3-month and 6-month follow-up visits to estimate total energy intake throughout the study. Patients complete questionnaires at baseline and periodically during study assessing demographic characteristics and established breast cancer risk factors, medical history, and health changes. Weight, adiposity as measured by waist circumference, quality of life, and depressive symptomology are assessed at baseline and at the 3- and 6-month follow-up visits.

After completion of the study intervention, patients are followed for up to 6 months.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

380 participants

Allocation:

Randomized

Primary Purpose:

Supportive Care

Official Title:

A Physical Activity Intervention to Prevent Weight Gain in Breast Cancer Patients

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Outcome Measures

Primary Outcome Measures

Accrual (phase I) []
Retention (phase I) []
Weight change after 6 months (phase II) []

Secondary Outcome Measures

Adiposity as measured by waist circumference at 3 and 6 months []
Health-related quality of life as measured by the Short-Form Health Survey-12 Physical and Mental Component Summary scales []
Depressive symptomology as measured by the Center for Epidemiologic Studies Depression Scale []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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