Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy
Condition: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Nausea; Vomiting
Intervention: dexamethasone; gabapentin; placebo
Intervention description: Given orally; Given orally; Given orally
Intervention MeSH terms: Dexamethasone; Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 430.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nausea and vomiting; unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Gabapentin may prevent or reduce delayed nausea and vomiting caused by
      chemotherapy. It is not yet known whether gabapentin is more effective than a placebo in
      preventing nausea and vomiting.

      PURPOSE: This randomized phase III trial is studying the side effects of gabapentin and to
      see how well it works compared with a placebo in preventing nausea and vomiting in patients
      receiving chemotherapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Scheduled to receive highly emetogenic chemotherapy

               -  May be scheduled to receive prophylactic treatment for acute nausea and vomiting
                  with a 5HT3 antagonist and dexamethasone 20 mg on day 1 of chemotherapy treatment

               -  May be scheduled to receive multiple day chemotherapy regimens as long as the
                  chemotherapy drugs given on the subsequent days have mild or no emetogenic
                  potential

          -  Chemotherapy schedules must allow at least 7 days rest between courses involving
             administration of highly emetogenic chemotherapy

          -  No primary CNS malignancy and/or CNS metastasis

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Life expectancy ≥ 3 months

          -  Creatinine ≤ 1.5 times upper limit of normal within the past 30 days

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Ability to complete questionnaire(s) by his/herself or with assistance

          -  Able to swallow pills

          -  No epilepsy or seizure history

          -  No gastrointestinal obstruction, active peptic ulcer disease, or uncontrolled
             heartburn

          -  No history of nausea and/or vomiting related to any kind of chemotherapy

          -  No nausea or vomiting within the past 3 days

          -  No history of allergic or other adverse reaction to gabapentin or pregabalin

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior moderate or highly emetogenic chemotherapy

          -  No prior or concurrent aprepitant or any other NK-1 receptor antagonist

          -  At least 1 months since prior and no concurrent gabapentin, pregabalin, or other
             anticonvulsants

          -  At least 7 days since prior and no concurrent pelvic or abdominal radiotherapy

          -  At least 3 days since prior antiemetics

          -  No concurrent or planned use of lorazepam, diphenhydramine, eszopiclone, and/or
             dronabinol during the 6 days of this study, except for treatment of breakthrough
             nausea and vomiting