Phase 3
N=191
Pregabalin in Treating Women With Hot Flashes
Breast Cancer · Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT00702949 ↗Enrolled (actual)
191
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). — -9.6; -6.1 units on a scale — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pregabalin (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). |
-9.6; -6.1 | 0.007 sig |
| PRIMARY Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). |
-71.0; -50.1 | 0.007 sig |
| SECONDARY Numerical Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). |
-4.6; -4.9; -2.9 | — |
| SECONDARY Percent Change From Baseline in Hot Flash Frequency at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). |
-58.5; -61.1; -36.3 | — |
| SECONDARY Comparison of 75 mg of Pregabalin vs Placebo, Numerical Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). |
-9.7; -6.1 | 0.002 sig |
| SECONDARY Comparison of 75 mg of Pregabalin vs Placebo. Percent Change From Baseline in Hot Flash Score at Treatment Week 6 (Positive Numbers to Represent Increases and Negative Numbers to Represent Decreases). |
-64.9; -50.1 | 0.009 sig |
| SECONDARY Toxicity Data for the Individual Study Arms From the Symptom Experience Diary . |
1.0; 2.0; 1.0; 1.0; 2.0; 1.0 | — |
| SECONDARY Mood and Hot Flash-related Daily Interference on Activities After 6 Weeks of Treatment |
-1.0; -1.5; -1; -1; -1.5; 0 | — |
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 cancer. It is not yet known what dose of pregabalin may be more effective in treating hot flashes.
PURPOSE: This is a randomized phase III trial to determine the efficacy of two doses of pregabalin, in comparison to placebo, in the prevention of hot flashes.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00702949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.