Survival TRaining for ENhancing Total Health (STRENGTH)

NCT00068458 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-12-19

No results posted yet for this study

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

Interventions

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.

OTHER

Exercise + Fruit & Vegetable, Low Fat + Calcium Diet

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Duke University

    lead OTHER

Principal Investigators

  • Edward G. Shaw, MD · Wake Forest University Health Sciences

  • Wendy Demark-Wahnefried, PhD · Duke Cancer Institute

  • Roger T. Anderson, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2004-01-31
Completion
2005-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00068458 on ClinicalTrials.gov