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

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. Identifier: NCT00509626
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : February 12, 2010
National Cancer Institute (NCI)
Information provided by:
Fox Chase Cancer Center

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2007
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Accrual (phase I)
  2. Retention (phase I)
  3. Weight change after 6 months (phase II)

Secondary Outcome Measures :
  1. Adiposity as measured by waist circumference at 3 and 6 months
  2. Health-related quality of life as measured by the Short-Form Health Survey-12 Physical and Mental Component Summary scales
  3. Depressive symptomology as measured by the Center for Epidemiologic Studies Depression Scale

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


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


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


  • See Disease Characteristics
  • No neoadjuvant chemotherapy

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 identifier (NCT number): NCT00509626

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)
Study Chair: Penny Anderson, MD Fox Chase Cancer Center Identifier: NCT00509626     History of Changes
Other Study ID Numbers: CDR0000555830
P30CA006927 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: February 12, 2010
Last Verified: February 2010

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

Additional relevant MeSH terms:
Breast Neoplasms
Body Weight
Weight Gain
Body Weight Changes
Neoplasms by Site
Breast Diseases
Skin Diseases
Behavioral Symptoms
Signs and Symptoms