A Study to find out the effectiveness of Gabapentin on patients who develop pain due to oral mucositis while they are on chemo-radaition therapy with Head and Neck Cancers with the site of tumor at the following regions (oral & oropharynx versus larynx & hypopharynx).

A randomized study to evaluate the effectiveness of Gabapentin on Oral-Mucositis induced pain due to chemo-radio therapy in patients with head and neck cancers.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/03/024269

Enrollment

154

Registered

2020-03-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Gabapentin: All eligible subjects will be randomized in a 1:1 ratio to one of the following two treatment arms: Arm A- local Anesthetic ( Benzocaine 20% w/w gel)+Tramadol. Arm B- local

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 to 70-years 2. Histologically or cytologically confirmed head and neck cancers receiving CTRT 3. Presence of radiation induced mucositis grade 1 or above 4. Pain related to mucositis on Visual analogue scale of 1 or more 5. ECOG PS 0-2 6. Normal haematological parameters a. Hematologic: Absolute neutrophil count (ANC) >= 1.5 Ã? 109/L, platelet count >= 100 Ã? 109/L, and hemoglobin >= 9 g/dL (may have been transfused) 7. Normal Liver functions a. Total bilirubin level <= 1.5 Ã? the upper limit of normal (ULN-1.2 mg/dl) range and AST and ALT levels <= 2.5 Ã? ULN ( AST/ALT <50 U/L)

Exclusion criteria

Exclusion criteria: 1. Use of analgesic for more than 1 week X 2. Deranged serum creatinine > 1.5ULN 3. Known allergy to tramadol

Design outcomes

Primary

Measure	Time frame
Primary Objective is to Evaluate the Pain scores at baseline, post 1st dose of analgesic and at day 7Timepoint: 1. Pain score at baseline (on Visual analogue scale) and first dose of analgesic and at day 7 would be noted.	—

Secondary

Measure	Time frame
To compare the compliance and adverse eventsTimepoint: After completion of treatment;To compare the QOL week 1 post randomisation andat the end of CTRT between the 2 armsTimepoint: 3. To compare the QOL week 1 post randomisation andat the end of CTRT between the 2 arms;To compare the rate of change or escalation of analgesic post 1 week of start of studied analgesic in the treatment of CTRT induced mucositis pain in patients with HNC.Timepoint: 1. To compare the rate of change or escalation of analgesic post 1 week of start of studied analgesic;Treatment delayTimepoint: After completion of treatment	—

Measure

Time frame

To compare the compliance and adverse eventsTimepoint: After completion of treatment;To compare the QOL week 1 post randomisation andat the end of CTRT between the 2 armsTimepoint: 3. To compare the QOL week 1 post randomisation andat the end of CTRT between the 2 arms;To compare the rate of change or escalation of analgesic post 1 week of start of studied analgesic in the treatment of CTRT induced mucositis pain in patients with HNC.Timepoint: 1. To compare the rate of change or escalation of analgesic post 1 week of start of studied analgesic;Treatment delayTimepoint: After completion of treatment

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Countries

India

Contacts

Public ContactDr Vijay M Patil

Tata Memorial Hospital

vijaypgi@gmail.com9869382266

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 5, 2026