Clinical trial · Interventional
Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy
Phase III Double-Blind, Placebo-Controlled Study of Gabapentin for the Prevention of Delayed CINV (Chemotherapy Induced Nausea and Vomiting) in Patients Receiving Highly Emetogenic Chemotherapy
NCT00880191CI-TRIAL-00022885completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nausea and Vomiting | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| gabapentin | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.
- interventionNames
- Drug: dexamethasone
- Drug: gabapentin
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.
- interventionNames
- Drug: dexamethasone
- Other: placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.