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Clinical Trials/CTRI/2020/03/024269
CTRI/2020/03/024269
Not yet recruiting
Phase 3

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.

Tata Memorial Hospital0 sites0 target enrollmentTBD

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Sponsor
Tata Memorial Hospital
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility 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

  • 1\.Use of analgesic for more than 1 week X
  • 2\.Deranged serum creatinine \> 1\.5ULN
  • 3\.Known allergy to tramadol

Outcomes

Primary Outcomes

Not specified

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