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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:
ClinicalTrials.gov Identifier:
NCT00509626
First Posted: July 31, 2007
Last Update Posted: February 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fox Chase Cancer Center
  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)
  • 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509626


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

ClinicalTrials.gov Identifier: NCT00509626     History of Changes
Other Study ID Numbers: CDR0000555830
P30CA006927 ( U.S. NIH Grant/Contract )
FCCC-FCRB-05-009
First Submitted: July 30, 2007
First Posted: July 31, 2007
Last Update Posted: February 12, 2010
Last Verified: February 2010

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:
Breast Neoplasms
Depression
Body Weight
Fatigue
Weight Gain
Body Weight Changes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Signs and Symptoms