Survival TRaining for ENhancing Total Health (STRENGTH)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT00068458
First received: September 10, 2003
Last updated: April 3, 2013
Last verified: April 2013
  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: 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.


Condition Intervention Phase
Breast Cancer
Depression
Weight Changes
Dietary Supplement: Calcium-Rich Diet
Other: Arm 2: Exercise + Calcium-Rich Diet
Other: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Wake Forest Cancer Center CCOP Research Base:

Primary Outcome Measures:
  • Distance Medicine Based Diet Exercise Program Within the Cooperative Group Setting [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assess estimates of effect sizes and to ascertain potential feasibility of implementing a distance-medicine based diet-exercise program within the cooperative group setting.


Enrollment: 39
Study Start Date: September 2003
Study Completion Date: January 2005
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: calcium diet
Calcium-Rich Diet (dietary counseling + materials promoting an intake of 1,200 - 2,500 mg/day).
Dietary Supplement: Calcium-Rich Diet
1,200 - 2,500 mg/day. 6 month intervention
Other Name: Calcium
Active Comparator: Arm 2: Exercise + Calcium-Rich Diet
Exercise + Calcium Rich Diet (dietary counseling + materials promoting strength training and aerobic activity + a calcium intake of 1,200 - 2,500 mg/day).
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.
Other Name: Calcium
Active Comparator: 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.
Other: Exercise + Fruit & Vegetable, Low Fat + Calcium Diet
1,200 - 2,500 Calcium intake per day. 6 month intervention period.
Other Name: Calcium

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068458

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States, 27534
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1030
United States, South Carolina
Cancer Centers of the Carolinas - Eastside
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Wake Forest Cancer Center CCOP Research Base
Investigators
Study Chair: Edward G. Shaw, MD Comprehensive Cancer Center of Wake Forest University
Principal Investigator: Wendy Demark-Wahnefried, PhD Duke Cancer Institute
Study Chair: Roger T. Anderson, PhD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier: NCT00068458     History of Changes
Other Study ID Numbers: CCCWFU 97301, U10CA081851
Study First Received: September 10, 2003
Last Updated: April 3, 2013
Health Authority: United States: Federal Government

Keywords provided by Wake Forest Cancer Center CCOP Research Base:
weight changes
depression
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Body Weight Changes
Breast Neoplasms
Depression
Depressive Disorder
Body Weight
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014