Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
North Central Cancer Treatment Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00880191
First received: April 10, 2009
Last updated: February 5, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nausea and Vomiting Unspecified Adult Solid Tumor, Protocol Specific |
Drug: dexamethasone Drug: gabapentin Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Gabapentin
Gabapentin enacarbil
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Comparison of percentage of complete responders, with complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6 [ Designated as safety issue: No ]
- Complete response, defined as no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale, and no rescue agents [ Designated as safety issue: No ]
- Comparison of percentages of complete responders on day 1, vs days 1 through 6 vs days 2 through 6 [ Designated as safety issue: No ]
- Comparison of the proportion of patients experiencing emetic episodes and the proportion needing rescue agents [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Comparison fo sum of the daily distress questions as well as the individual daily responses [ Designated as safety issue: No ]
- Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary as well as the nausea subscale on the Functional Living Index - Emesis questionnaire [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Comparison of daily complete response endpoints [ Designated as safety issue: No ]
| Estimated Enrollment: | 416 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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
Given orally
Drug: gabapentin
Given orally
|
|
Experimental: Arm II
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
Given orally
Other: placebo
Given orally
|
Detailed Description:
OBJECTIVES:
- To evaluate the effectiveness of gabapentin in controlling delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy as defined by the percentage of complete responders (no emetic episodes and no rescue medication) on days 2 through 6 (five days after receipt of highly emetogenic chemotherapy) compared to an effective prophylactic regimen.
- To evaluate the effectiveness of gabapentin in controlling delayed CINV in patients receiving highly emetogenic chemotherapy as defined by the percentage of complete responders (no emetic episodes, no more than mild nausea, and no rescue medication) on days 2 through 6 compared to an effective prophylactic regimen.
- To compare the effectiveness of these regimens in controlling acute CINV on day 1 of treatment in these patients.
- To compare the use of rescue agents in these patients.
- To determine the tolerability of gabapentin in these patients.
- To evaluate the effect of gabapentin for delayed chemotherapy-induced nausea and vomiting on symptom distress and functional abilities in these patients.
- To compare alternative endpoints and methods for assessing nausea and vomiting and to determine how these measures compare to patient's satisfaction with symptom control, distress and function.
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.
- Arm I: 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.
- Arm II: 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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880191
Show 247 Study Locations
Show 247 Study LocationsSponsors and Collaborators
North Central Cancer Treatment Group
Investigators
| Principal Investigator: | Debra Barton, RN, PhD, AOCN, FAAN | Mayo Clinic |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00880191 History of Changes |
| Other Study ID Numbers: | CDR0000634077, NCCTG-N08C3 |
| Study First Received: | April 10, 2009 |
| Last Updated: | February 5, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
nausea and vomiting unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Gabapentin BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Anticonvulsants Antiparkinson Agents |
ClinicalTrials.gov processed this record on May 23, 2013