Phase 3
Completed N=413
Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy
Nausea and vomiting · Unspecified Adult Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT00880191 ↗
Enrolled (actual)
413
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Comparison of Percentage of Complete Responders — 53.1; 59.2; 46.9; 40.8 percentage of participants — p=0.2344
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Percentage of Complete Responders |
53.1; 59.2; 46.9; 40.8 | 0.2344 |
| SECONDARY Complete Response |
56; 60.7; 44; 39.3 | 0.3694 |
| SECONDARY Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6. |
32.4; 33.5; 67.6; 66.5; 60.4; 63.6 | — |
| SECONDARY Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents |
55; 47; 45; 53; 70; 70 | — |
| SECONDARY Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses |
1.1; 1.2; 0.9; 1.1; 0.9; 1.2 | — |
| SECONDARY Level of Satisfaction for the Control of Nausea. |
8.3; 8.1; 2.8; 2.9 | — |
| SECONDARY Comparison of Daily Complete Response Endpoints |
32.4; 33.5; 67.6; 66.5; 26.6; 36.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT00880191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.