Breast CancerNCT00031811
Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer
A study testing raloxifene and quality-of-life assessment in people with Breast Cancer and Menopausal Symptoms, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Menopausal Symptoms, Osteoporosis
- What is being tested?
- raloxifene and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Apr 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97201-3098
About this study
Official title: Breast Cancer Survivors: Exercise and Raloxifene
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.
Read the 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.
- Conditions
- Breast Cancer, Menopausal Symptoms, Osteoporosis
- Being tested
- raloxifene, quality-of-life assessment
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, osteoporosis, menopausal symptoms
- Medical subject headings
- Breast Neoplasms, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raloxifeneDrug
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2003 (estimated)
- Study startMar 2001
- Primary completionApr 2003
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anna Schwartz, FNP, PhD, Study chair, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031811
- Sponsor's protocol ID
- CDR0000069229
- Other IDs
- OHSU-6312, NCI-H02-0086
- Status last verified
- Jun 2010
- First submitted
- 8 Mar 2002
- Last updated
- 28 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Survivors: Exercise and Raloxifene
- ClinicalTrials.gov ID
- NCT00031811
- Acronym / sponsor ID
- CDR0000069229
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2001
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 6 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| raloxifene | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Schwartz, FNP, PhD study chair
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing raloxifene and quality-of-life assessment in people with Breast Cancer and Menopausal Symptoms, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2012.