Prophylactic Pregabalin for Head and Neck Radiotherapy Patients - Pilot

Phase 2

• Conditions: Radiotherapy-related pain; Cancer - Head and neck

• Registration Number: ACTRN12618001794291
• Lead Sponsor: South Eastern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-02
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Gender: male and female
•Age: >18 years
•ECOG 0-2
•Patients receiving curative radiotherapy to the head and neck area to treat mucosal squamous cell carcinomas (SCC), with or without chemotherapy/cetuximab
•Both P16 positive and negative SCC (a known variant in histology)
•Patients undergoing radiotherapy (RT) as both adjuvant and radical treatment
•Willingness to give written informed consent

Exclusion Criteria

•Patients receiving palliative radiotherapy to the head and neck.
•Patients in whom pregabalin is contraindicated E.g.
ointolerance or allergy to pregabalin/gabapentin
opatients on buprenorphine or propoxyphene
•Patients on neuroleptic medication or other neuropathic agents for other medical conditions
•Inability to provide informed consent
•Inability to complete the visual aspects of the questionnaires without assistance (other then explanation)
•Patients with moderate/severe renal impairment with GFR (glomerular filtration rate) of <50ml/min as calculated according to Cockroft-Gault formula using screening blood test
•Platelet count <100
•Absolute neutrophil count <1.5x109/L
•Alanine aminotransferase (ALT) >2.5x upper limit of normal
•Patients who are pregnant or lactating
•Previous suicidal ideation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients who contiue on trial to completion. This will be assessed by audit of attendance logs[6 weeks post-treatment and 1 year post-treatment];Proportion of patients who tolerate doses of pregabalin above 225mg twice per day. This will be assessed by data linkage to medical records.[6 weeks post-treatment];proportion of patients who have accurate and complete radiotherapy-related pain assessments. This will be assessed by audit of attendance logs[6-weeks post treatment and 1 year post-treatment]

Secondary Outcome Measures

Name	Time	Method
il- this is a Pilot study.[N/A]