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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00702949 |
RATIONALE: Pregabalin may help relieve hot flashes in women who do not wish to take estrogen therapy for fear of increased risk of breast cancer. It is not yet known which dose of pregabalin may be more effective in treating hot flashes.
PURPOSE: This randomized phase III trial is studying the side effects of two doses of pregabalin and to see how well it works compared with a placebo in treating women with hot flashes.
Condition | Intervention | Phase |
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Breast Cancer Hot Flashes |
Drug: pregabalin Other: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes |
Estimated Enrollment: | 192 |
Study Start Date: | June 2008 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive 75 mg of oral pregabalin twice daily for 6 weeks.
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Drug: pregabalin
Given orally
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Arm II: Experimental
Patients receive 150 mg of oral pregabalin twice daily for 6 weeks.
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Drug: pregabalin
Given orally
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Arm III: Placebo Comparator
Patients receive oral placebo twice daily for 6 weeks.
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Other: placebo
Given orally
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OBJECTIVES:
OUTLINE: Patients are stratified according to age (18-49 years vs ≥ 50 years); selective estrogen-receptor modulator (i.e., tamoxifen or raloxifene) or aromatase inhibitor use (yes vs no); duration of hot flashes (< 9 months vs ≥ 9 months); and frequency of hot flashes per 24-hour period (4-9 vs ≥ 10). Patients are randomized to
1 of 3 treatment arms.
Patients complete Hot Flash Diaries at baseline and once daily during treatment and the Symptom Experience Diary at baseline and once weekly during treatment. Patients also complete the Profile of Mood States and the Hot Flash Related Daily Interference Scale questionnaires at baseline and after completion of study treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents
No concurrent or planned use of other agents for hot flashes except for any of the following:
Study Chair: | Charles L. Loprinzi, MD | Mayo Clinic |
Responsible Party: | North Central Cancer Treatment Group ( Charles L. Loprinzi ) |
Study ID Numbers: | CDR0000598191, NCCTG-N07C1 |
Study First Received: | June 19, 2008 |
Last Updated: | June 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00702949 History of Changes |
Health Authority: | United States: Federal Government |
breast cancer breast cancer hot flashes |
Signs and Symptoms Skin Diseases Hot Flashes Pregabalin Breast Neoplasms |
Peripheral Nervous System Agents Analgesics Anticonvulsants Breast Diseases |
Skin Diseases Physiological Effects of Drugs Hot Flashes Breast Neoplasms Pregabalin Pharmacologic Actions Signs and Symptoms Neoplasms |
Neoplasms by Site Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Breast Diseases |