Gabapentin in Preventing Nausea and Vomiting in Patients... | NCT00880191

ID	Type	Description	Link
NCI-2009-01110	Registry Identifier	CTRP (Clinical Trials Reporting System)
CDR0000634077	Registry Identifier	PDQ (Physician Data Query)

Status Module

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Label	Type	Description	Intervention Names
Arm I	Experimental	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
Arm II	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
dexamethasone	Drug	Given orally	Arm I Arm II
gabapentin

Measure	Description	Time Frame
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.	Days 2 through 6

Measure	Description	Time Frame
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.	Days 2-6
Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.

Eligibility Module

Name	Affiliation	Role
Debra Barton, RN, PhD, AOCN, FAAN	Mayo Clinic	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Scottsdale		Scottsdale	Arizona	85259-5499	United States
Aurora Presbyterian Hospital

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Gabapentin	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. > dexamethasone: Given orally > gabapentin: Given orally

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Number

percentage of participants

Days 2 through 6

ID	Title	Description
OG000	Gabapentin	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. > dexamethasone: Given orally > gabapentin: Given orally
OG001	Placebo	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. > dexamethasone: Given orally > placebo: Given orally

Units	Counts
Participants	OG000207 OG001206

Title

Denominators

Categories

Response Days 2-6: No

Title	Measurements
	OG00053.1 OG00159.2

Response Days 2-6: Yes

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Complete Responders by Arm - Days 2-6, the primary analysis utilizes Fisher's exact test to compare the percentage of complete responders in each group (dex/gabapentin vs. dex/placebo), with 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.	Fisher Exact		0.2344						2-Sided							No	Superiority or Other

Secondary

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.

Posted

Number

percentage of participants

Days 2-6

ID	Title	Description
OG000	Gabapentin	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. > dexamethasone: Given orally > gabapentin: Given orally
OG001	Placebo	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. > dexamethasone: Given orally > placebo: Given orally

Units	Counts
Participants

Secondary

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.

Posted

Number

percentage of participants

Days 1 through 6

ID	Title	Description
OG000	Gabapentin	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. > dexamethasone: Given orally > gabapentin: Given orally
OG001	Placebo	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. > dexamethasone: Given orally > placebo: Given orally

Secondary

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.

Posted

Number

percentage of participants

Days1 through 6

ID	Title	Description
OG000	Gabapentin	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. > dexamethasone: Given orally > gabapentin: Given orally
OG001	Placebo	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. > dexamethasone: Given orally > placebo: Given orally

Units	Counts
Participants

Secondary

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.

Posted

Mean

Standard Deviation

units on a scale

Days 1 through 6

ID	Title	Description
OG000	Gabapentin	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. > dexamethasone: Given orally > gabapentin: Given orally
OG001	Placebo	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. > dexamethasone: Given orally > placebo: Given orally

Units	Counts
Participants

Secondary

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)

203 patients in Gabapentin arm and 201 patients in Placebo arm submitted the data for this endpoint.

Posted

Mean

Standard Deviation

units on a scale

Days 1 through 6

ID	Title	Description
OG000	Gabapentin	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. > dexamethasone: Given orally > gabapentin: Given orally
OG001	Placebo	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. > dexamethasone: Given orally > placebo: Given orally

Secondary

Comparison of Daily Complete Response Endpoints

Daily complete response is defined as no emetic episodes and no use of rescue therapy.

Posted

Number

percentage of participants

Days 1 through 6

ID	Title	Description
OG000	Gabapentin	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. > dexamethasone: Given orally > gabapentin: Given orally
OG001	Placebo	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. > dexamethasone: Given orally > placebo: Given orally

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected206 at risk
Vision blurred	Eye disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected206 at risk
Constipation	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected207 at risk EG0012 events2 affected206 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected207 at risk EG0011 events1 affected206 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0006 events6 affected207 at risk EG0013 events3 affected206 at risk
Flatulence	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Mucositis oral	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected206 at risk
Nausea	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0005 events5 affected207 at risk EG0011 events1 affected206 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected207 at risk EG0013 events3 affected206 at risk
Edema limbs	General disorders	MedDRA 10	Systematic Assessment	EG00019 events19 affected207 at risk EG00118 events18 affected206 at risk
Fatigue	General disorders	MedDRA 10	Systematic Assessment	EG0002 events2 affected207 at risk EG0011 events1 affected206 at risk
Localized edema	General disorders	MedDRA 10	Systematic Assessment	EG0003 events3 affected207 at risk EG0019 events9 affected206 at risk
Pain	General disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Device related infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected206 at risk
Pneumonia	Infections and infestations	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Skin infection	Infections and infestations	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Alanine aminotransferase increased	Investigations	MedDRA 10	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected206 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Blood glucose increased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected206 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Serum sodium decreased	Metabolism and nutrition disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Ataxia	Nervous system disorders	MedDRA 10	Systematic Assessment	EG00013 events13 affected207 at risk EG00123 events23 affected206 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 10	Systematic Assessment	EG00016 events16 affected207 at risk EG00117 events17 affected206 at risk
Dizziness	Nervous system disorders	MedDRA 10	Systematic Assessment	EG00058 events57 affected207 at risk EG00159 events59 affected206 at risk
Headache	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0005 events5 affected207 at risk EG0013 events3 affected206 at risk
Ischemia cerebrovascular	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected206 at risk
Speech disorder	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected206 at risk
Syncope	Nervous system disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Confusion	Psychiatric disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected206 at risk
Renal failure	Renal and urinary disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected206 at risk
Hiccough	Respiratory, thoracic and mediastinal disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk
Hypertension	Vascular disorders	MedDRA 10	Systematic Assessment	EG0001 events1 affected207 at risk EG0010 events0 affected206 at risk
Thrombosis	Vascular disorders	MedDRA 10	Systematic Assessment	EG0000 events0 affected207 at risk EG0011 events1 affected206 at risk

ID	Title	Description
BG000	Gabapentin	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.> dexamethasone: Given orally> gabapentin: Given orally
BG001	Placebo	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.> dexamethasone: Given orally> placebo: Given orally
BG002	Total	Total of all reporting groups

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D000588	Amines
D009930	Organic Chemicals
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D003509	Cyclohexanecarboxylic Acids
D000146	Acids, Carbocyclic
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Gabapentin	gabapentin: Given orally			0	207	95	207
EG001	Placebo	placebo: Given orally			0	206	96	206