Survival TRaining for ENhancing Total Health (STRENGTH)

NCT00068458 | Completed Phase 2 DMC

• 1 other identifier: U10CA081851
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Cancer; Depression; Weight Changes

Keywords

weight changes; depression; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Arm 1: calcium diet

ACTIVE COMPARATOR

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

Dietary Supplement: Calcium-Rich Diet

Arm 2: Exercise + Calcium-Rich Diet

ACTIVE COMPARATOR

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

Exercise + Fruit & Vegetable, Low Fat + Calcium Diet

ACTIVE COMPARATOR

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

Interventions

Calcium-Rich Diet DIETARY_SUPPLEMENT

1,200 - 2,500 mg/day. 6 month intervention

Also known as: Calcium

Arm 1: calcium diet

Arm 2: Exercise + Calcium-Rich Diet OTHER

Dietary counseling + material promoting strength training an aerobic activity + a calcium intake of 1,200 - 2,500 mg/day. 6 month intervention.

Also known as: Calcium

Arm 2: Exercise + Calcium-Rich Diet

Exercise + Fruit & Vegetable, Low Fat + Calcium Diet OTHER

1,200 - 2,500 Calcium intake per day. 6 month intervention period.

Also known as: Calcium

Exercise + Fruit & Vegetable, Low Fat + Calcium Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1030, United States

Location

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, 29615, United States

Location

Related 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 Cancer. 2008 Feb;8(1):70-9. doi: 10.3816/CBC.2008.n.005.

  PMID: 18501061 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Depression; Body Weight Changes

Interventions

Calcium; Exercise; Fruit; Vegetables; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena

Study Officials

• Edward G. Shaw, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

• Wendy Demark-Wahnefried, PhD

  Duke Cancer Institute

  PRINCIPAL INVESTIGATOR

• Roger T. Anderson, PhD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2003
• First Posted: September 11, 2003
• Study Start: September 1, 2003
• Primary Completion: January 1, 2004
• Study Completion: January 1, 2005
• Last Updated: December 19, 2017

Record last verified: 2013-04

Locations

US (4)