Gabapentin in the Prevention of Nausea and Vomiting Induced by Chemotherapy

• Sponsor: Faculdade de Medicina do ABC (Other)
• Overall Status: Completed
• CT.gov ID: NCT01052844
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 17.9
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

Gabapentin is an antiepileptic drug. Its antiemetic effect is demonstrated after laparoscopic surgery, but it is not yet known whether gabapentin is effective in preventing chemotherapy induced emesis.

The purpose of this study is to determine whether the addition of gabapentin to dexamethasone plus ondansetron increase the control of chemotherapy-induced nausea and vomiting.

Condition or Disease	Intervention/Treatment	Phase
Vomiting; Cisplatin Adverse Reaction	Drug: Placebo; Drug: Gabapentin	Phase 3

Detailed Description

This was a prospective, double-blind, placebo-controlled study conducted at our institution (Faculdade de Medicina da Fundação ABC and affiliated Hospitals) from April 2009 to April 2010. Patients and personnel involved in the study were blinded to the assigned treatment. The study was approved by the ethics committee of our institution. All the patients provided written informed consent.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Trial of Gabapentin in the Prevention of Nausea Ond Vomiting Induced by Chemotherapy, a Randomized, Double-blind, Placebo Controled Study
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group Placebo: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily	Drug: Placebo; Placebo, given orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3)
Experimental: Gabapentin Gabapentin 300mg: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily	Drug: Gabapentin; Gabapentin 300mg, orally Ranitide 50 mg, IV, before chemotherapy (D1) Ondansetron 8 mg, IV, before chemotherapy (D1) Dexamethasone 10 mg, IV, before chemotherapy (D1) Dexamethasone 4 mg, PO, 2x/day (D2, D3)

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Complete Response During Chemotherapy Course 1 [5 days]

   The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)

2. Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 [6 days]

   Complete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• First course of chemotherapy ( cisplatin or doxorubicin at a dose of at least 50mg per square meter)

• Written informed consent must be obtained before initiating the protocol procedures

Exclusion Criteria:

• ECOG 3

• Nausea and vomiting within the past 1 day

• Gastrointestinal obstruction

• Concurrent use of opioid

• Patients with brain metastases

• History of allergic or other adverse reaction to gabapentin

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculdade de Medicina do ABC	Santo André	São Paulo	Brazil	09060-650

Sponsors and Collaborators

• Faculdade de Medicina do ABC

Investigators

• Study Director: Auro del Giglio, phD, Faculdade de Medicina do ABC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Felipe Melo Cruz, MsC, Faculdade de Medicina do ABC
• ClinicalTrials.gov Identifier: NCT01052844
• Other Study ID Numbers: ABC-2009
• First Posted: Jan 20, 2010
• Last Update Posted: Mar 7, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Felipe Melo Cruz, MsC, Faculdade de Medicina do ABC: Vomiting; Antiemetics; Dexamethasone; Cisplatin; Antineoplastic combined chemotherapy protocols
• Additional relevant MeSH terms: Vomiting; Gabapentin

Study Results

Participant Flow

Recruitment Details	This was a prospective, double-blind, placebo-controlled study conducted at our institution (Faculdade de Medicina da Fundação ABC and affiliated Hospitals) from April 2009 to April 2010. Patients and personnel involved in the study were blinded to the assigned treatment.
Pre-assignment Detail	Patients and personnel involved in the study were blinded to the assigned treatment. The study was approved by the ethics committee of our institution. All the patients provided written informed consent. No enrolled participants were excluded from the trial.

Arm/Group Title	Control Group	Gabapentin
Arm/Group Description	Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy Placebo: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily	Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy Gabapentin 300mg: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
Period Title: Overall Study
STARTED	40	40
COMPLETED	40	39
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Control Group	Gabapentin	Total
Arm/Group Description	Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy Placebo: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily	Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy Gabapentin 300mg: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily	Total of all reporting groups
Overall Participants	40	40	80
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	34 85%	34 85%	68 85%
>=65 years	6 15%	6 15%	12 15%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.3 (10.4)	55.6 (9.9)	53.9 (10.2)
Sex: Female, Male (Count of Participants)
Female	39 97.5%	36 90%	75 93.8%
Male	1 2.5%	4 10%	5 6.3%
Region of Enrollment (participants) [Number]
Brazil	40 100%	40 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Complete Response During Chemotherapy Course 1
Description	The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h)
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Gabapentin
Arm/Group Description	Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy Placebo: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily	Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy Gabapentin 300mg: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
Measure Participants	40	40
Number [participants]	17 42.5%	26 65%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Gabapentin
	Comments	Complete protection from nausea and vomiting (CP) was defined as the absence of any episode of nausea or vomiting and no use of rescue medication. CP was further defined as either acute (ACP), when occurring during the first 24 hours after chemotherapy; delayed (DCP), when occurring during the period from days 2 through 5 after chemotherapy; or overall, when occurring over the entire period of the study (first 120 hours).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Chi-squared
	Comments

2. Primary Outcome

Title	Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1
Description	Complete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy
Time Frame	6 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Gabapentin
Arm/Group Description	Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy Placebo: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily	Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy Gabapentin 300mg: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
Measure Participants	40	40
Number [participants]	21 52.5%	29 72.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Gabapentin
	Comments	We evaluated associations between categorical variables using the Chi-Square test
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	Adverse event data were colected from day 1 to day 6 after chemotherapy
Arm/Group Title	Control Group		Gabapentin
Arm/Group Description	Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy Placebo: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily		Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1) Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy Gabapentin 300mg: Five and four days before chemotherapy (day -5 and day -4): 1x daily Three and two days before chemotherapy (day -3 and day -2): 2x daily One day before to five days after chemotherapy ( day -1 to day 5): 3x daily
All Cause Mortality
	Control Group		Gabapentin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Gabapentin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Control Group		Gabapentin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/40 (55%)		23/40 (57.5%)
Ear and labyrinth disorders
Dizziness	13/40 (32.5%)	13	18/40 (45%)	18
Gastrointestinal disorders
Diarrhoea	5/40 (12.5%)	5	5/40 (12.5%)	5
Constipation	12/40 (30%)	12	18/40 (45%)	18
Xerostomia	19/40 (47.5%)	19	23/40 (57.5%)	23
Heartburn	10/40 (25%)	10	13/40 (32.5%)	13
Nervous system disorders
Sleepiness	19/40 (47.5%)	19	18/40 (45%)	18

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.