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).
Phase 3
- Conditions
- Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
- Registration Number
- CTRI/2020/03/024269
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
1.Use of analgesic for more than 1 week X
2.Deranged serum creatinine > 1.5ULN
3.Known allergy to tramadol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method