Trial Outcomes & Findings for Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy (NCT NCT02480114)

Last Updated: 2021-02-18

Results Overview

The pain subscale is composed of 4 items of the Vanderbilt Head and Neck Symptom Survey. The subscale score was calculated by taking the first non-negative principle component of the 4 items. The scale was scores range from 0 to 10 with 10 representing the worst pain.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

79 participants

Primary outcome timeframe

Up to 3 months post-treatment

Results posted on

2021-02-18

Participant Flow

Participants were enrolled at Vanderbilt Medical Center in Nashville, TN from July 2015 to May 2019. 79 participants were recruited and 8 of those withdrew.

Participant milestones

Participant milestones
Measure	Arm II Standard of Care Plus Gabapentin Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis	Arm I Standard of Care Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management.
Overall Study STARTED	41	38
Overall Study COMPLETED	32	30
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm II Standard of Care Plus Gabapentin Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis	Arm I Standard of Care Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management.
Overall Study Not completing surveys	3	2
Overall Study Withdrawal by Subject	2	4
Overall Study Disease progression	3	0
Overall Study Improper completion of survey	1	1
Overall Study Not eligible	0	1

Baseline Characteristics

Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I Standard of Care n=38 Participants Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management. Educational Intervention: Undergo oral care and pain management education session Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis	Arm II Standard of Care Plus Gabapentin n=41 Participants Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis	Total n=79 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=99 Participants	34 Participants n=107 Participants	66 Participants n=206 Participants
Age, Categorical >=65 years	6 Participants n=99 Participants	7 Participants n=107 Participants	13 Participants n=206 Participants
Age, Continuous	61.5 Years n=99 Participants	61 Years n=107 Participants	61 Years n=206 Participants
Sex: Female, Male Female	12 Participants n=99 Participants	14 Participants n=107 Participants	26 Participants n=206 Participants
Sex: Female, Male Male	26 Participants n=99 Participants	27 Participants n=107 Participants	53 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) White	33 Participants n=99 Participants	39 Participants n=107 Participants	72 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Region of Enrollment United States	38 participants n=99 Participants	41 participants n=107 Participants	79 participants n=206 Participants

PRIMARY outcome

Timeframe: Up to 3 months post-treatment

Population: Longitudinal analysis was completed including all patients in both arms of the study. Although some patients stopped filling out surveys part way through the study and therefore are not marked as 'complete' in the patient flow section, the data they did provide was still used for analysis.

Outcome measures

Outcome measures
Measure	Arm I Standard of Care n=32 Participants Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management. Educational Intervention: Undergo oral care and pain management education session Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis	Arm II Standard of Care Plus Gabapentin n=39 Participants Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis
Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS))	4.26 score on a scale Interval 3.98 to 5.16	3.68 score on a scale Interval 2.04 to 3.68

SECONDARY outcome

Timeframe: Up to 3 months post-treatment

Population: All patients in both arms were analyzed. Although some patients stopped filling out surveys part way through the study and therefore are not marked as 'complete' in the patient flow section, the data they did provide was still used for analysis.

Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p \< 0.05). Frequency distributions will summarize the safety outcome.

Outcome measures

Outcome measures
Measure	Arm I Standard of Care n=32 Participants Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management. Educational Intervention: Undergo oral care and pain management education session Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis	Arm II Standard of Care Plus Gabapentin n=39 Participants Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis
Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 3 months post-treatment

Population: Although some patients stopped filling out surveys part way through the study and therefore are not marked as 'complete' in the patient flow section, the data they did provide was still used for analysis.

Pain severity will be correlated with frequency and severity of general systemic symptoms. Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p \< 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome. The General Symptom Survey is a ten item patient reported outcome measure and outcomes were averaged as there is only one item per symptom category. 0 represented no presence of the symptom with a score of 10 representing the most severe symptom.

Outcome measures

Outcome measures
Measure	Arm I Standard of Care n=32 Participants Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management. Educational Intervention: Undergo oral care and pain management education session Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis	Arm II Standard of Care Plus Gabapentin n=39 Participants Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis
Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form)	1.91 score on a scale Interval 0.73 to 3.56	1.23 score on a scale Interval 0.45 to 2.79

Adverse Events

Arm I Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II Standard of Care Plus Gabapentin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I Standard of Care n=38 participants at risk Patients receive standard of care consisting of oral health measures, oral rinsing, miracle mouthwash, nonsteroidal anti-inflammatories, and opioid analgesics. Patients also undergo an education session at the beginning of treatment to review foundations of oral care and pain management. Educational Intervention: Undergo oral care and pain management education session Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis	Arm II Standard of Care Plus Gabapentin n=41 participants at risk Patients receive standard of care and undergo an education session as in Arm I. Patients also receive gabapentin PO three times a day throughout chemoradiation treatment (approximately 5-7 weeks) and until mucositis resolves and pain subsides. Educational Intervention: Undergo oral care and pain management education session Gabapentin: Given PO Pain Therapy: Receive usual oral health care Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Oxycodone/Acetaminophen: Analgesia Hydrocodone/Acetaminophen: Analgesia Fentanyl: Transdermal Analgesia Ibuprofen: NSAID Analgesia Magic Mouthwash: Oral Solution to treat mucositis
General disorders Fatigue	0.00% 0/38 • Approximately 3 months after completion of treatment	4.9% 2/41 • Number of events 2 • Approximately 3 months after completion of treatment

Additional Information

Derek Smith, DDS, PhD

Vanderbilt University Medical Center

Phone: 6159367423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place