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

NCT ID: NCT00509626

Last Updated: 2010-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30

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.

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.

Conditions

Breast Cancer; Depression; Fatigue; Psychosocial Effects of Cancer and Its Treatment; Weight Changes

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

exercise intervention

Intervention Type: BEHAVIORAL

questionnaire administration

Intervention Type: OTHER

CAM exercise therapy

Intervention Type: PROCEDURE

management of therapy complications

Intervention Type: PROCEDURE

psychosocial assessment and care

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

• Treatment plan includes trastuzumab (Herceptin®) or bevacizumab
• Recurrent breast cancer

PATIENT CHARACTERISTICS:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Penny Anderson, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

P30CA006927

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FCCC-FCRB-05-009

Identifier Type: -

Identifier Source: secondary_id

CDR0000555830

Identifier Type: -

Identifier Source: org_study_id