Survival TRaining for ENhancing Total Health (STRENGTH)

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068458
• Other study ID #: U10CA081851
• Secondary ID: U10CA081851
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2003
• Last updated: December 15, 2017
• Start date: September 2003
• Est. completion date: January 2005

Study information

• Verified date: April 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2005
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Body Weight Changes
• Breast Cancer
• Breast Neoplasms
• Depression
• Weight Changes

Intervention

Dietary Supplement:
• Calcium-Rich Diet
1,200 - 2,500 mg/day. 6 month intervention

Other:
• Arm 2: Exercise + Calcium-Rich Diet
Dietary counseling + material promoting strength training an aerobic activity + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.
• Exercise + Fruit & Vegetable, Low Fat + Calcium Diet
1,200 - 2,500 Calcium intake per day. 6 month intervention period.

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Cancer Centers of the Carolinas - Eastside	Greenville	South Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Demark-Wahnefried W, Case LD, Blackwell K, Marcom PK, Kraus W, Aziz N, Snyder DC, Giguere JK, Shaw E. Results of a diet/exercise feasibility trial to prevent adverse body composition change in breast cancer patients on adjuvant chemotherapy. Clin Breast C — View Citation

Outcome

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