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

NCT00509626 | Completed Phase 1

• 3 other identifiers: CDR0000555830P30CA006927FCCC-FCRB-05-009
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

fatigue; psychosocial effects of cancer and its treatment; weight changes; depression; stage I breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (3)

• Accrual (phase I)

• Retention (phase I)

• Weight change after 6 months (phase II)

Secondary Outcomes (3)

• 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

Interventions

exercise intervention BEHAVIORAL

questionnaire administration OTHER

CAM exercise therapy PROCEDURE

management of therapy complications PROCEDURE

psychosocial assessment and care PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• 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
• 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)

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Depression; Fatigue; Body Weight Changes

Interventions

Exercise Therapy; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Penny Anderson, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: July 31, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2008
• Last Updated: February 12, 2010

Record last verified: 2010-02

Locations

US (1)