Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Gabapentin; gamma-Aminobutyric Acid

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