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Breast Cancer Survivors: Exercise and Raloxifene


N/A
N/A
N/A
Not Enrolling
Female
Breast Cancer, Menopausal Symptoms, Osteoporosis

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Trial Information

Breast Cancer Survivors: Exercise and Raloxifene


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Anna Schwartz, FNP, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000069229

NCT ID:

NCT00031811

Start Date:

March 2001

Completion Date:

April 2003

Related Keywords:

  • Breast Cancer
  • Menopausal Symptoms
  • Osteoporosis
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • osteoporosis
  • menopausal symptoms
  • Breast Neoplasms
  • Osteoporosis

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239