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

Primary Purpose

Breast Cancer, Menopausal Symptoms, Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
raloxifene
quality-of-life assessment
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, osteoporosis, menopausal symptoms

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • OHSU Knight Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
May 24, 2012
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00031811
Brief Title
Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
Official Title
Breast Cancer Survivors: Exercise and Raloxifene
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Menopausal Symptoms, Osteoporosis
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, osteoporosis, menopausal symptoms

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
raloxifene
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Schwartz, FNP, PhD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States

12. IPD Sharing Statement

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

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