Pregabalin in Treating Women With Hot Flashes

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pregabalin

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