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Trial record 25 of 35 for:    breast cancer weight gain

Survival TRaining for ENhancing Total Health (STRENGTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00068458
Recruitment Status : Completed
First Posted : September 11, 2003
Last Update Posted : December 19, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment 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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : September 2003
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Distance Medicine Based Diet Exercise Program Within the Cooperative Group Setting [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over


  • 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


  • Not specified


  • Not specified


  • No calcium-based kidney stones


  • No angina within the past 6 months
  • No myocardial infarction within the past 6 months
  • No abnormal MUGA and/or stress test


  • 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


Biologic therapy

  • Not specified


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • Not specified


  • No prior bilateral oophorectomy
  • No prior amputation
  • No concurrent transverse rectus abdominis myocutaneous surgery
  • No concurrent surgery


  • No concurrent blood-thinners (e.g., coumadin or warfarin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00068458

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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
Duke University
National Cancer Institute (NCI)
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Study Chair: Edward G. Shaw, MD Wake Forest University Health Sciences
Principal Investigator: Wendy Demark-Wahnefried, PhD Duke Cancer Institute
Study Chair: Roger T. Anderson, PhD Wake Forest University Health Sciences

Publications of Results:
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Responsible Party: Duke University Identifier: NCT00068458     History of Changes
Other Study ID Numbers: U10CA081851 ( U.S. NIH Grant/Contract )
U10CA081851 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2003    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: April 2013

Keywords provided by Duke University:
weight changes
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Body Weight Changes
Neoplasms by Site
Breast Diseases
Body Weight
Skin Diseases
Behavioral Symptoms
Signs and Symptoms
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents