Pregabalin in Treating Women With Hot Flashes
Condition: Breast Cancer; Hot Flashes
MeSH terms: Hot Flashes
Intervention: pregabalin; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 207.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: breast cancer; hot flashes

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