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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00031811
First received: March 8, 2002
Last updated: May 24, 2012
Last verified: June 2010
  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
Menopausal Symptoms
Osteoporosis
Drug: raloxifene
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Breast Cancer Survivors: Exercise and Raloxifene

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Enrollment: 80
Study Start Date: March 2001
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97201-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Study Chair: Anna Schwartz, FNP, PhD OHSU Knight Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00031811     History of Changes
Other Study ID Numbers: CDR0000069229, OHSU-6312, NCI-H02-0086
Study First Received: March 8, 2002
Last Updated: May 24, 2012
Health Authority: United States: Federal Government

Keywords provided by OHSU Knight Cancer Institute:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
osteoporosis
menopausal symptoms

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

ClinicalTrials.gov processed this record on August 25, 2014