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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00509626
First received: July 30, 2007
Last updated: February 11, 2010
Last verified: February 2010
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: A Physical Activity Intervention to Prevent Weight Gain in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Accrual (phase I) [ Designated as safety issue: No ]
  • Retention (phase I) [ Designated as safety issue: No ]
  • Weight change after 6 months (phase II) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adiposity as measured by waist circumference at 3 and 6 months [ Designated as safety issue: No ]
  • Health-related quality of life as measured by the Short-Form Health Survey-12 Physical and Mental Component Summary scales [ Designated as safety issue: No ]
  • Depressive symptomology as measured by the Center for Epidemiologic Studies Depression Scale [ Designated as safety issue: No ]

Estimated Enrollment: 380
Study Start Date: June 2007
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509626

Locations
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Penny Anderson, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00509626     History of Changes
Other Study ID Numbers: CDR0000555830, P30CA006927, FCCC-FCRB-05-009
Study First Received: July 30, 2007
Last Updated: February 11, 2010
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
fatigue
psychosocial effects of cancer and its treatment
weight changes
depression
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Breast Neoplasms
Depression
Depressive Disorder
Fatigue
Weight Gain
Behavioral Symptoms
Breast Diseases
Mental Disorders
Mood Disorders
Neoplasms
Neoplasms by Site
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014