Survival TRaining for ENhancing Total Health (STRENGTH)

Phase 2

Completed

• Conditions: Breast Cancer; Depression; Weight Changes
• Interventions: Dietary Supplement: Calcium-Rich Diet; Other: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet

• Registration Number: NCT00068458
• Lead Sponsor: Duke University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2003-09-10
• Study First Submitted QC: 2003-09-10
• Study First Posted: 2003-09-11
• Primary Completion: 2004-01
• Study Completion: 2005-01
• Status Verified: 2013-04
• Last Update Submitted: 2017-12-15
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: calcium diet	Calcium-Rich Diet	Calcium-Rich Diet (dietary counseling + materials promoting an intake of 1,200 - 2,500 mg/day).
Exercise + Fruit & Vegetable, Low Fat + Calcium Diet	Exercise + Fruit & Vegetable, Low Fat + Calcium Diet	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.

Primary Outcome Measures

Name	Time	Method
Distance Medicine Based Diet Exercise Program Within the Cooperative Group Setting	6 months	Assess estimates of effect sizes and to ascertain potential feasibility of implementing a distance-medicine based diet-exercise program within the cooperative group setting.

Trial Locations

Locations (4)

Duke Comprehensive Cancer Center; 🇺🇸 Durham, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

Southeastern Medical Oncology Center; 🇺🇸 Goldsboro, North Carolina, United States

Cancer Centers of the Carolinas - Eastside; 🇺🇸 Greenville, South Carolina, United States