NCT02480114View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

September 30, 2019

Study Completion Date

January 31, 2020

Conditions
Malignant Head and Neck NeoplasmMucositisRadiation-Induced Disorder
Interventions
OTHER

Educational Intervention

Undergo oral care and pain management education session

DRUG

Gabapentin

Given PO

OTHER

Pain Therapy

Receive usual oral health care

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Oxycodone/Acetaminophen

Analgesia

DRUG

Hydrocodone/Acetaminophen

Analgesia

DRUG

Fentanyl

Transdermal Analgesia

DRUG

Ibuprofen

NSAID Analgesia

DRUG

Magic Mouthwash

Oral Solution to treat mucositis

Trial Locations (1)

37232

Vanderbilt University/Ingram Cancer Center, Nashville

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Vanderbilt-Ingram Cancer Center

OTHER

NCT02480114 - 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 | Biotech Hunter | Biotech Hunter