Physical Activity in Preventing Breast Cancer in Women With a History of Breast Cancer or at High Risk for Breast Cancer Who Are Not Physically Active - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00095849

Purpose

RATIONALE: Physical activity may be effective in preventing the development or recurrence of breast cancer.

PURPOSE: This randomized clinical trial is studying physical activity to see how well it works in preventing breast cancer in women with a history of breast cancer or who are at high risk for breast cancer who are not physically active.

Condition	Intervention
Breast Cancer	Behavioral: exercise intervention

Study Type:	Observational
Official Title:	A Pilot Study Of A Three Month Intervention For Increasing Physical Activity In Sedentary Women At Risk For Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Increase in physical activity as assessed by step count after 12 weeks of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Biomarkers (e.g., estradiol, c-reactive protein, insulin-like growth factor 1 [IGF-1], and high-density lipoprotein [HDL]) after 12 weeks of treatment [ Designated as safety issue: No ]
Body composition (e.g., waist circumference, hip circumference, and % body fat) after 12 weeks of treatment [ Designated as safety issue: No ]
Fitness as assessed by a 6-minute walk-run test after 12 weeks of treatment [ Designated as safety issue: No ]
Quality of life as assessed by SF-36, CES-D, BSI, and PSS after 12 weeks of treatment [ Designated as safety issue: No ]

Estimated Enrollment:	175
Study Start Date:	September 2004

Detailed Description:

OBJECTIVES:

Primary

Compare the rate of compliance in sedentary women with a history of breast cancer or at high risk for breast cancer undergoing a physical activity intervention comprising walking using a pedometer vs stretching.
Compare the efficacy of these interventions, in terms of increased physical activity, in these patients.

Secondary

Correlate physical activity, as measured by a pedometer, with self-report of exercise on the Modifiable Activity Questionnaire in patients undergoing the physical activity intervention.
Compare modulation of high-density lipoprotein, insulin-like growth factor I, estradiol, and c-reactive protein in patients undergoing these interventions.
Compare multidimensional quality of life in patients undergoing these interventions.
Correlate pedometer measurements of daily step counts with accelerometer measurements in patients undergoing the physical activity intervention.
Compare the functional capacity, as measured by the six-minute walk test, of patients undergoing these interventions.
Compare the body composition, as measured by anthropometry and bioelectrical impedance, of patients undergoing these interventions.
Determine if these three month physical activity intervention changes the long term physical activity behavior of patients as measured by a pedometer and a self report one year following the intervention.
Examine post-program exercise motivation and adherence of patients undergoing these interventions.

OUTLINE: This is a randomized, pilot study. All patients wear pedometers for 1 week (without changing activity level) to assess activity level. Patients deemed sedentary are randomized to 1 of 2 arms.

Arm I (walking): Patients wear a pedometer daily for 12 weeks. Patients receive an exercise prescription outlining weekly step count goals and a motivational and educational pamphlet.
Arm II (stretching): Patients receive instruction on stretching exercises and keep a stretching exercise log book for 12 weeks.

In both arms, intervention continues in the absence of injury or illness.

Patients complete the Modifiable Activity Questionnaire at baseline and then at weeks 4, 8, and 12. Quality of life is assessed at baseline and then at week 12.

PROJECTED ACCRUAL: A total of 175 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Meets criteria for 1 of the following:
- History of stage I, II, or III invasive breast cancer
  - At least 2 months since completion of primary therapy, including surgery, radiotherapy, or chemotherapy
  - No metastatic or recurrent disease
- At high risk for breast cancer, defined by meeting 1 of the following criteria:
  - Gail model risk ≥ 1.7% over 5 years OR Claus model lifetime risk of > 20%
  - Lobular neoplasia
  - Atypical ductal hyperplasia
  - Ductal carcinoma in situ that has been previously treated with mastectomy or lumpectomy and radiotherapy, with or without tamoxifen or an aromatase inhibitor
  - Deleterious mutations in BRCA1 or BRCA2 OR a prior risk assessment of ≥ 20% chance of carrying a BRCA1/2 gene mutation
Sedentary, defined as a weekly leisure-time activity score of ≤ 15 on the Godin Leisure-Time Exercise Questionnaire (i.e., engaging in moderate activity < 3 times a week)
Able to perform the level of on-study physical activity, as determined by the Physical Activity Readiness Questionnaire
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

18 to 75

Sex

Female

Menopausal status

Not specified

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Cardiovascular

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
No recent myocardial infarction or stroke

Other

Not pregnant
Negative pregnancy test (if premenopausal)
Able to complete study questionnaires OR has a willing friend or family member to assist in questionnaire completion
No ongoing or active infection
No psychiatric illness or social situation that would preclude giving informed consent or study compliance
No other malignancy within the past 2 years except invasive breast cancer or squamous cell or basal cell skin cancer
No other uncontrolled illness
No physical condition that would preclude the amount of daily walking prescribed on study (e.g., severe arthritis or use of a wheelchair, walker, or cane)

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

See Disease Characteristics
Concurrent hormonal therapy (e.g., tamoxifen or aromatase inhibitors) allowed provided patient has completed at least 2 months of therapy before study enrollment

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095849

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:	Larissa Korde, MD, MPH	National Cancer Institute (NCI)
Investigator:	Sheila A. Prindiville, MD	National Institutes of Health (NIH)
Principal Investigator:	Giuseppe Giaccone, MD, PhD	NCI - Medical Oncology Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000393790, NCI-04-C-0276, NCI-NAVY-B05-001
Study First Received:	November 9, 2004
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00095849 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

ductal breast carcinoma in situ
stage IIIC breast cancer
lobular breast carcinoma in situ
breast cancer in situ

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010