A Phase 3 interventional study of dexamethasone and gabapentin in Nausea and Vomiting and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Alliance for Clinical Trials in Oncology. Completed at 247 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-06.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Supportive care
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.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to gender, age (\< 50 years vs > 50 years), history of alcoholism (yes vs no), and history of motion sickness or history of pregnancy induced nausea/vomiting (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients complete a Functional Living Index - Emesis questionnaire, an overall satisfaction survey, and a side effect experience diary at baseline and on day 6. Patients also complete a nausea and vomiting diary at baseline and periodically during study therapy.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 430 is above the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Scheduled to receive highly emetogenic chemotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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.
Drug: dexamethasone · Drug: gabapentin
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.
Drug: dexamethasone · Other: placebo
Given orally
Given orally
Given orally
Comparison of Percentage of Complete Responders
Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.
Time frame: Days 2 through 6
Complete Response
The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale (0 - 10 (As bad as it could be)), and no rescue agents.
Time frame: Days 2-6
Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.
The percentages of complete responders on day 1, vs. days 1 through 6 vs. days 2 through 6 will be compared between arms. Complete response being defined as no emetic episodes and no use of rescue therapy. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.
Time frame: Days 1 through 6
Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents
The percentage of patients experiencing emetic episodes and the percentage needing rescue agents was compared between groups.
Time frame: Days1 through 6
Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses
The sum of the daily distress questions as well as the individual daily responses from the Nausea and Vomiting Diary (NVD) on a 0-10 scale (Lower score is better) will be compared.
Time frame: Days 1 through 6
Level of Satisfaction for the Control of Nausea.
Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary (on a 0 - 10 scale, higher the better) as well as the nausea subscale on the Functional Living Index - Emesis (FLIE) questionnaire ( 1-7 scale, lower the better)
Time frame: Days 1 through 6
Comparison of Daily Complete Response Endpoints
Daily complete response is defined as no emetic episodes and no use of rescue therapy.
Time frame: Days 1 through 6
430 patients were enrolled on this study. There are 17 cancelled patients, 7 on the gabapentin arm and 10 on the placebo arm.
| Milestone | Gabapentin | Placebo |
|---|---|---|
| Started | 207 | 206 |
| Available for primary endpoint analysis | 207 | 206 |
| Completed | 194 | 198 |
| Not completed | 13 | 8 |
| Withdrew: Refused further treatment | 4 | 1 |
| Withdrew: Adverse event | 8 | 6 |
| Withdrew: Hospitalization/efficacy | 1 | 1 |
Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.
| percentage of participants | Gabapentin | Placebo |
|---|---|---|
| Response Days 2-6: No | 53.1 | 59.2 |
| Response Days 2-6: Yes | 46.9 | 40.8 |
The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale (0 - 10 (As bad as it could be)), and no rescue agents.
| percentage of participants | Gabapentin | Placebo |
|---|---|---|
| Response Days 2-6: No | 56 | 60.7 |
| Response Days 2-6: Yes | 44 | 39.3 |
The percentages of complete responders on day 1, vs. days 1 through 6 vs. days 2 through 6 will be compared between arms. Complete response being defined as no emetic episodes and no use of rescue therapy. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.
| percentage of participants | Gabapentin | Placebo |
|---|---|---|
| Response Day 1: No | 32.4 | 33.5 |
| Response Day 1: Yes | 67.6 | 66.5 |
| Response Day 1-6: No | 60.4 | 63.6 |
| Response Day 1-6: Yes | 39.6 | 36.4 |
| Response Day 2-6: No | 62.3 | 65 |
| Response Day 2-6: Yes | 37.7 | 35 |
The percentage of patients experiencing emetic episodes and the percentage needing rescue agents was compared between groups.
| percentage of participants | Gabapentin | Placebo |
|---|---|---|
| Rescue Agent Status: No | 55 | 47 |
| Rescue Agent Status: Yes | 45 | 53 |
| Emetic Status: No | 70 | 70 |
| Emetic Status: Yes | 30 | 30 |
The sum of the daily distress questions as well as the individual daily responses from the Nausea and Vomiting Diary (NVD) on a 0-10 scale (Lower score is better) will be compared.
| units on a scale | Gabapentin | Placebo |
|---|---|---|
| NVD Nausea Distress Day 1 | 1.1 ± 2.3 | 1.2 ± 2.2 |
| NVD Nausea Distress Day 2 | 0.9 ± 1.9 | 1.1 ± 1.7 |
| NVD Nausea Distress Day 3 | 0.9 ± 1.9 | 1.2 ± 2.2 |
| NVD Nausea Distress Day 4 | 0.7 ± 1.6 | 1.1 ± 1.9 |
| NVD Nausea Distress Day 5 | 0.9 ± 1.9 | 1.1 ± 1.8 |
| NVD Nausea Distress Day 6 | 0.8 ± 1.8 | 0.9 ± 1.7 |
| NVD Nausea Distress Sum Days 1-6 | 5.1 ± 8.0 | 6.4 ± 8.9 |
Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary (on a 0 - 10 scale, higher the better) as well as the nausea subscale on the Functional Living Index - Emesis (FLIE) questionnaire ( 1-7 scale, lower the better)
| units on a scale | Gabapentin | Placebo |
|---|---|---|
| Satisfaction Nausea Control (0-10 scale) | 8.3 ± 2.8 | 8.1 ± 2.9 |
| FLIE Nausea Subscale Day 6 | 2.8 ± 1.0 | 2.9 ± 1.0 |
Daily complete response is defined as no emetic episodes and no use of rescue therapy.
| percentage of participants | Gabapentin | Placebo |
|---|---|---|
| Response Day 1: No | 32.4 | 33.5 |
| Response Day 1: Yes | 67.6 | 66.5 |
| Response Day 2: No | 26.6 | 36.4 |
| Response Day 2: Yes | 73.4 | 63.6 |
| Response Day 3: No | 22.2 | 34.5 |
| Response Day 3: Yes | 77.8 | 65.5 |
| Response Day 4: No | 19.3 | 30.1 |
| Response Day 4: Yes | 80.7 | 69.9 |
| Response Day 5: No | 32.9 | 34.0 |
| Response Day 5: Yes | 67.1 | 66.0 |
| Response Day 6: No | 28.0 | 31.6 |
| Response Day 6: Yes | 72.0 | 68.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gabapentin | — | 0/207 (0%) | 95/207 (45.9%) |
| Placebo | — | 0/206 (0%) | 96/206 (46.6%) |
| Event | Gabapentin | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 57/207 | 59/206 |
| AtaxiaNervous system disorders | 13/207 | 23/206 |
| Edema limbsGeneral disorders | 19/207 | 18/206 |
| Depressed level of consciousnessNervous system disorders | 16/207 | 17/206 |
| Localized edemaGeneral disorders | 3/207 | 9/206 |
| DyspepsiaGastrointestinal disorders | 6/207 | 3/206 |
| NauseaGastrointestinal disorders | 5/207 | 1/206 |
| HeadacheNervous system disorders | 5/207 | 3/206 |
| VomitingGastrointestinal disorders | 3/207 | 3/206 |
| DiarrheaGastrointestinal disorders | 3/207 | 1/206 |
| Age, Customized(participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| <50 Years | 57 | 58 | 115 |
| >=50 Years | 150 | 148 | 298 |
| Sex: Female, Male(Participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| Female | 145 | 145 | 290 |
| Male | 62 | 61 | 123 |
| Region of Enrollment(participants) | Gabapentin | Placebo | Total |
|---|---|---|---|
| United States | 207 | 206 | 413 |
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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology