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

This study is no longer recruiting patients.

Sponsors and Collaborators: Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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: Randomizedphase II trial to compare 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 Treatment or Intervention Phase
weight changes
Quality of Life
Depression
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
 Procedure: complications of therapy assessment/management
 Procedure: quality-of-life assessment
 Procedure: supportive care/therapy
Phase II

MedlinePlus related topics:  Breast Cancer;   Depression
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: STRENGTH (Survival TRaining for ENhancing Total Health): Phase II Randomized Pilot Study of Distance Medicine-Based Exercise and Dietary Approach to Prevent Body Composition Change During Adjuvant Chemotherapy in Patients With Stage I, II, or IIIA Breast Cancer

Further Study Details: 

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 above,  Genders Eligible for Study:  Both

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)

Location Information


North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1030,  United States

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

      Southeastern Medical Oncology Center, Goldsboro,  North Carolina,  27534,  United States

South Carolina
      Cancer Centers of the Carolinas - Eastside, Greenville,  South Carolina,  29615,  United States

Study chairs or principal investigators

Edward G. Shaw, MD,  Study Chair,  Comprehensive Cancer Center of Wake Forest University   
Wendy Demark-Wahnefried, PhD,  Duke Comprehensive Cancer Center   
Roger T. Anderson, PhD,  Comprehensive Cancer Center of Wake Forest University   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000322831; CCCWFU-97301; CCCWFU-BG02-196; CCCWFU-00-29(A)
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  September 10, 2003
ClinicalTrials.gov Identifier:  NCT00068458
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005