Prophylactic Pregabalin for Head and Neck Radiotherapy Patients - Pilot

INTERVENTION: Arm 1: Prophylactic Pregabalin ‐ Oral, taken in addition to standard of care analgesia given to treat radiotherapy‐related pain Pregabalin starting dose = 75mg twice per day for 3 days Increase dose as follows: 75mg in the morning and 150mg in the evening for 3 days 150mg twice per day for 3 days 150mg in the morning and 225mg in the evening for 3 days 225mg twice per day for 3 days 225mg in the morning and 300mg in the evening for 3 days 300mg twice per day to continue as tolerated The threshold effective dose for trial purposes will be any dose including or higher than 225mg twice per day Pregabalin will be taken orally, however, if patients become unable to take capsules orally during the course of radiotherapy, they can take pregabalin via feeding tube by opening the capsule and dissolving the contents of the capsule in sterile water. Treatment Cessation: Start down titration of pregabalin in a similar schedule to escalation at the same time and rate of opiate reduction (i.e. from 2‐6 weeks following treatment, as clinically indicated). i.e. once pain scores reduce and oral nutrition increases, reduce pregabalin as follows 225mg in the morning and 300mg in the evening for 3 days 225mg twice per day for 3 days 150mg in the morning and 225mg in the evening for 3 days 150mg twice per day for 3 days 75mg in the morning and 150mg in the evening for 3 days 75mg twice per day for 3 days Stop all pregabalin Dose Adjustments: If patients develop G1‐2 toxicity (CTCAEv4) related to pregabalin, pregabalin doses should be reduced to the next dose band down (i.e. reduce by 75mg at a time) until side‐effects are tolerable. Aim to treat patients with the highest tolerable dose. If patients develop G3 or G4 toxicity related to pregabalin, or persistent G1 or 2 toxicity with pregabalin, the drug will be stopped. Pregabalin will not be given to patients taking buprenorphine or propoxyphene. If p CONDITION: Cancer ‐ Head and neck Radiotherapy‐related pain; ; Radiotherapy‐related pain PRIMARY OUTCOME: 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 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] 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] SECONDARY OUTCOME: Nil‐ this is a Pilot study.[N/A] 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