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Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Oregon Health and Science University Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031811
  Purpose

RATIONALE: Raloxifene and exercise may improve bone health and quality of life in breast cancer survivors. Assessing bone health and quality of life may improve the ability to plan treatment.

PURPOSE: Randomized clinical trial to study the effectiveness of raloxifene with or without exercise compared with exercise alone in women who have been previously treated for breast cancer.


Condition Intervention
Breast Cancer
Cancer-Related Problem/Condition
Drug: raloxifene
Procedure: quality-of-life assessment

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Exercise and Physical Fitness   

Drug Information available for:   Raloxifene    Raloxifene hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Placebo Control
Official Title:   Breast Cancer Survivors: Exercise and Raloxifene

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 2001

Detailed Description:

OBJECTIVES:

  • Determine the effects of raloxifene with or without exercise versus exercise alone on bone reabsorption rate, bone formation rate, and bone density in women previously treated for breast cancer.
  • Determine the effects of these regimens on the quality of life of these patients.

OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are randomized to one of four treatment arms.

  • Arm I: Patients are asked to exercise 5 days a week with instruction. Patients also receive oral placebo once daily.
  • Arm II: Patients receive oral raloxifene once daily.
  • Arm III: Patients are asked to exercise as in arm I. Patients also receive oral raloxifene once daily.
  • Arm IV: Patients receive oral placebo once daily. All patients receive oral calcium supplements once daily. Treatment continues in all arms for 24 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and every 3 months during study.

PROJECTED ACCRUAL: A total of 240 patients (60 per treatment arm) will be accrued for this study.

  Eligibility
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer
  • No metastatic disease
  • At least 3 months but no more than 1 year since prior chemotherapy regimen including doxorubicin or methotrexate and catabolic steroids (to prevent nausea, vomiting, fluid retention, or hypersensitivity reactions)
  • No routine of regular strenuous exercise (more than 90 minutes per day 6 days/week OR 120 minutes per day 4 days/week)
  • Hormone receptor status:

    • Estrogen and progesterone receptor negative OR
    • Estrogen and progesterone receptor positive

PATIENT CHARACTERISTICS:

Age:

  • Any age

Sex:

  • Female

Menopausal status:

  • Postmenopausal (at diagnosis OR chemotherapy-induced)
  • No spontaneous menses for more than 6 months with increased follicle-stimulating hormone and decreased estradiol

Performance status:

  • Ambulatory

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No cardiac problems that would preclude exercise
  • No unstable angina

Pulmonary:

  • No respiratory problems that would preclude exercise
  • No chronic obstructive pulmonary disease
  • No oxygen dependence

Other:

  • No endocrine disease (e.g., parathyroid hormone disorders) that would accelerate bone turnover and loss
  • No musculoskeletal problems or other disease that would preclude exercise (e.g., movement-limiting arthritis, muscular dystrophy, or chronic fatigue syndrome)
  • No known cognitive or psychiatric disorders that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • Prior adjuvant or neoadjuvant chemotherapy allowed
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent tamoxifen

Radiotherapy:

  • Prior adjuvant radiotherapy after chemotherapy allowed
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No concurrent bisphosphonates
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031811

Locations
United States, Oregon
Oregon Cancer Center    
      Portland, Oregon, United States, 97201-3098

Sponsors and Collaborators
Oregon Health and Science University Cancer Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     Anna Schwartz, FNP, PhD     Oregon Health and Science University Cancer Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000069229, OHSU-6312, NCI-H02-0086
First Received:   March 8, 2002
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00031811
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer  
stage II breast cancer  
stage IIIA breast cancer  
stage IIIB breast cancer  
osteoporosis
quality of life
menopausal symptoms

Study placed in the following topic categories:
Raloxifene
Skin Diseases
Quality of Life
Osteoporosis
Breast Neoplasms
Menopause
Breast Diseases

Additional relevant MeSH terms:
Estrogen Receptor Modulators
Estrogen Antagonists
Neoplasms
Neoplasms by Site
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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