Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Women Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer - Full Text View

Sponsor:	Wake Forest University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00068458

Purpose

RATIONALE: A home-based exercise and/or diet program may improve the quality of life of breast cancer patients by preventing an increase in body fat and weight and a loss of lean body tissue.

PURPOSE: This randomized phase II trial is studying the effectiveness of three home-based diet and/or exercise programs in preventing weight gain and loss of muscle tissue in women who are receiving chemotherapy for stage I, stage II, or stage IIIA breast cancer.

Condition	Intervention	Phase
Breast Cancer Depression Weight Changes	Procedure: management of therapy complications Procedure: quality-of-life assessment	Phase II

Study Type:	Interventional
Study Design:	Randomized, Active Control
Official Title:	A Phase II Randomized Study to Assess the Feasibility of Distance Medicine Based Exercise and Dietary Approaches to Prevent Body Composition Change Occurring During Adjuvant Chemotherapy for Early Stage Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Depression Diets Exercise and Physical Fitness

U.S. FDA Resources

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

Study Start Date:

September 2003

Detailed Description:

OBJECTIVES:

Compare the efficacy of exercise alone or combined with a modified diet as home-based interventions to prevent increases in body fat during adjuvant chemotherapy in women with stage I, II, or IIIA breast cancer.
Compare the efficacy of these regimens, in terms of reducing gains in adipose tissue, reducing losses in absolute amounts of lean body tissue, reducing gains in weight, influencing levels of biomarkers associated with the risk of breast cancer and/or other comorbid conditions, improving self-efficacy for exercise behaviors, reducing depression, and improving quality of life in these patients.
Compare the adherence rates to these regimens in these patients.
Determine the associations between study condition and adherence and change in endpoints in patients treated with these regimens.
Determine the feasibility of conducting home-based exercise and diet studies using the infrastructure of the cooperative group.

OUTLINE: This is a pilot, randomized, multicenter study. Patients are stratified according to body mass index (no more than 25 kg/m^2 vs more than 25 kg/m^2), race (white vs non-white), and prior exercise history (vigorous exercise of at least 30 minutes, 3 times a week prior to diagnosis) (yes vs no). Patients are randomized to 1 of 3 treatment arms.

Arm I (calcium-rich diet): Patients receive materials and counseling to promote a diet that contains ample amounts of calcium (1,200-2,500 mg/day).
Arm II (calcium-rich diet and exercise): Patients receive materials and counseling as in arm I and instruction and materials to promote strength training and endurance exercises.
Arm III (calcium-rich, high fruit and vegetable, low-fat diet and exercise): Patients receive materials and counseling as in arm II and materials and counseling to consume at least 5 servings of vegetables and fruit per day and limit fat intake to less than 20% of total calories.

In all arms, patients continue regimens for 6 months.

Measurements of body composition, weight, waist circumference, serum levels of insulin, insulin-like growth factor, sex hormone-binding globulin, and total cholesterol are obtained at baseline and 6 months.

Quality of life, depression, diet composition, and physical activity are assessed at baseline and at 3 and 6 months.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 90 patients (30 per treatment arm) will be accrued for this study within 16 months.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer
- Stage I, II, or IIIA
Scheduled to receive adjuvant chemotherapy OR received 1 prior course of chemotherapy
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

18 and over

Sex

Female

Menopausal Status

Premenopausal, defined as at least 1 of the following:
- Less than 4 months since last menstrual period at diagnosis
- Follicle-stimulating hormone level in the premenopausal range

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

No calcium-based kidney stones

Cardiovascular

No angina within the past 6 months
No myocardial infarction within the past 6 months
No abnormal MUGA and/or stress test

Other

Not pregnant or nursing
Access to a telephone
Able to read and speak English
No other prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
No history of hyperthyroidism or hypothyroidism
No paralysis
No osteoarthritis with uncontrolled joint pain that would preclude exercise
No diverticulitis
No serious medical or psychiatric illness that would preclude giving informed consent or completing study therapy or quality of life questionnaires
No medical condition that would interfere with body composition assessment
No medical condition for which unsupervised exercise is contraindicated
No medical condition for which a high vegetable and fruit diet or a calcium-rich diet is contraindicated

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

No prior bilateral oophorectomy
No prior amputation
No concurrent transverse rectus abdominis myocutaneous surgery
No concurrent surgery

Other

No concurrent blood-thinners (e.g., coumadin or warfarin)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00068458

Locations

United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1030
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
United States, South Carolina
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, United States, 29615

Sponsors and Collaborators

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:	Edward G. Shaw, MD	Wake Forest University
Investigator:	Wendy Demark-Wahnefried, PhD	Duke University
Investigator:	Roger T. Anderson, PhD	Wake Forest University

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:	CDR0000322831, CCCWFU-97301, CCCWFU-BG02-196, CCCWFU-00-29(A)
Study First Received:	September 10, 2003
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00068458 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

weight changes
depression
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:

Depression
Skin Diseases
Breast Neoplasms
Depressive Disorder
Behavioral Symptoms
Body Weight
Signs and Symptoms

Neoplasms
Neoplasms by Site
Mental Disorders
Body Weight Changes
Mood Disorders
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009