Gabapentin in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00880191

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 III

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:

MedlinePlus related topics: Cancer Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone acetate Gabapentin Doxiproct plus Gabapentin enacarbil Dexamethasone Sodium Phosphate

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

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Debra Barton, RN, PhD, AOCN, FAAN

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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 February 09, 2012