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

NCT00031811 | Completed

• 3 other identifiers: CDR0000069229OHSU-6312NCI-H02-0086
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Interventions

raloxifene DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97201-3098, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis

Interventions

Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Anna Schwartz, FNP, PhD

  OHSU Knight Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2002
• First Posted: August 6, 2003
• Study Start: March 1, 2001
• Primary Completion: April 1, 2003
• Study Completion: April 1, 2003
• Last Updated: May 28, 2012

Record last verified: 2010-06

Locations

US (1)