Status:
COMPLETED
Pregabalin in Treating Women With Hot Flashes
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Pregabalin may help relieve hot flashes in women with a history of breast cancer or those who have no history and do not wish to take estrogen therapy for fear of increased risk of breast c...
Detailed Description
OBJECTIVES: * To evaluate the efficacy of 150 mg of pregabalin versus placebo on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear o...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Meeting 1 of the following criteria:
- History of breast cancer (currently without malignant disease)
- No history of breast cancer, but patient wishes to avoid estrogen due to a perceived increased risk of breast cancer
- Bothersome hot flashes (defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention)
- Presence of hot flashes for ≥ 1 month prior to study entry
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy ≥ 6 months
- Able to complete questionnaire(s) by themselves or with assistance
- Women of childbearing potential not eligible (per the judgment of the attending clinician)
- Serum creatinine ≤ 1.5 times upper limit of normal
- PRIOR CONCURRENT THERAPY:
- No prior gabapentin or pregabalin
- More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents
- Vaginal estrogen is allowed if used for the past month and not planned to be discontinued
- Concurrent adjuvant targeted therapy (i.e., lapatinib, trastuzumab \[Herceptin®\]) allowed in patients with no evidence of disease
- Concurrent tamoxifen, raloxifene, or aromatase inhibitors on a constant dose for at least 4 weeks allowed provided the medication will not be stopped during the study period
- No concurrent or planned use of other agents for hot flashes except for any of the following:
- Stable dose of vitamin E is allowed as long as agent was started \> 30 days prior to study initiation and is to be continued throughout the study period
- Soy is allowed, if it is planned to be continued at the same dose during the study period
- Stable dose of antidepressants is allowed as long as it was started \> 30 days prior to study initiation and is to be continued at a stable dose throughout the study period
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00702949
Start Date
June 1 2008
End Date
March 1 2015
Last Update
August 1 2016
Active Locations (209)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
3
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
4
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933