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| Descriptive Information Fields | |||||
| Brief Title † | Gabapentin For the Control of Hot Flashes in Women With Breast Cancer | ||||
| Official Title † | Control of Vasomotor Symptoms in Women Treated for Breast Cancer | ||||
| Brief Summary | RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes. PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and duration of hot flash symptoms (less than 9 months vs 9 or more months). Patients are randomized to 1 of 3 arms.
Treatment on all arms continues for 8 weeks in the absence of unacceptable toxicity. After week 8, patients may receive open-label gabapentin at the discretion of their physicians. Hot flashes are assessed at baseline and then during weeks 3 and 7 of the study. Quality of life, anxiety, and depression are assessed at baseline and then at weeks 4 and 8. Patients are followed at week 12. PROJECTED ACCRUAL: A total of 408 patients (136 per arm) will be accrued for this study within 18 months. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Supportive Care, Randomized, Open Label, Placebo Control | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Breast Cancer Cancer-Related Problem/Condition |
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| Intervention † | Drug: gabapentin Procedure: quality-of-life assessment |
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| MEDLINE PMIDs | 16139656 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | |||||
| Start Date † | July 2001 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00022074 | ||||
| Organization ID | CDR0000068780 | ||||
| Secondary IDs †† | URCC-U2101, NCI-P01-0183 | ||||
| Study Sponsor † | James P. Wilmot Cancer Center | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2003 | ||||
| First Received Date † | August 10, 2001 | ||||
| Last Updated Date | October 18, 2008 | ||||