None listed
Conditions
Brief summary
The purpose of this study is to investigate whether it is possible to treat patients who are receiving head/neck cancer radiotherapy with a drug called pregabalin, targeting pain before it has arisen. Who is it for? You may be eligible for this study if you are aged over 18 and are receiving curative radiotherapy to the head and neck area to treat squamous cell carcinoma Study details Participants in this study will be randomised (by chance) into one of two groups. One group will continue standard care, including radiotherapy treatment with standard pain-killers to treat the radiotherapy-related pain. The other group will take a medication called pregablin during the course of their radiotherapy. Pregabalin will be prescribed in addition to the standard pain-killers used to treat radiotherapy-related pain. All participants will receive standard of care radiotherapy and will undergo the routine tests required for treatment including scans before treatment and blood tests once a week whilst having radiotherapy. In addition, all patients in the trial will be asked to complete weekly pain questionnaires during radiotherapy and swallowing questionnaires at 6 weeks, 12 weeks, 24 weeks and 52 weeks after completion of radiotherapy. It is hoped this research will provide evidence to support a larger study to see Pregablin reduces the swallowing pain that is often experienced during head and neck radiotherapy.
Interventions
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 thres
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 possible buprenorphine/propoxyphene will be changed to a different analgesic before commencing on the trial. Stop treatment if patients develop severe thrombocytopenia (unrelated to chemotherapy), severe hypersensitivity reactions, suicidal ideation or seizures. Drug Accountability: Tablet counts will be performed each week to assess compliance with pregabalin. Patients will be asked to bring in all used blister packs for counting. Arm 2: Standard of Care analgesia to treat radiotherapy-related pain
Sponsors
South Eastern Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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. o intolerance or allergy to pregabalin/gabapentin o patients 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
Outcome results
None listed