Survival TRaining for ENhancing Total Health (STRENGTH)

Duke University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Weight Changes; Depression

Treatments: Other: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet; Other: Arm 2: Exercise + Calcium-Rich Diet; Dietary Supplement: Calcium-Rich Diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00068458

U10CA081851 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Arm 1: calcium diet

Active Comparator group

Description:

Calcium-Rich Diet (dietary counseling + materials promoting an intake of 1,200 - 2,500 mg/day).

Treatment:

Dietary Supplement: Calcium-Rich Diet

Arm 2: Exercise + Calcium-Rich Diet

Active Comparator group

Description:

Exercise + Calcium Rich Diet (dietary counseling + materials promoting strength training and aerobic activity + a calcium intake of 1,200 - 2,500 mg/day).

Treatment:

Other: Arm 2: Exercise + Calcium-Rich Diet

Exercise + Fruit & Vegetable, Low Fat + Calcium Diet

Active Comparator group

Description:

Dietary counseling + materials promoting strength training and aerobic activity + a diet that has \< 20% of energy coming from fat and intakes of fruits and vegetables of \> 5 servings/day + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.

Treatment:

Other: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet