Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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.
2. 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.
3. Compare the adherence rates to these regimens in these patients.
4. Determine the associations between study condition and adherence and change in endpoints in patients treated with these regimens.
5. Determine the feasibility of conducting home-based exercise and diet studies using the infrastructure of the cooperative group.

Entry 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

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)

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

Expected Enrollment

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

Outline

This is a pilot, randomized, multicenter study. Patients are stratified according to body mass index (no more than 25 kg/m² vs more than 25 kg/m²), 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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University CCOP Research Base

Edward Shaw, MD, Protocol chair		Ph: 336-716-0891; 800-446-2255 Email: eshaw@wakehealth.edu
Wendy Demark-Wahnefried, PhD, Protocol co-chair		Ph: 919-681-3261
Roger Anderson, PhD, Protocol co-chair		Ph: 336-716-7057; 800-446-2255

Registry Information
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
Trial Start Date		2003-09-22
Registered in ClinicalTrials.gov		NCT00068458
Date Submitted to PDQ		2003-07-18
Information Last Verified		2004-04-27
NCI Grant/Contract Number		R21-CA92468, P30-CA12197

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