ACTRN12618001794291
Not yet recruiting
Phase 2
Pilot Randomised Controlled Trial of Prophylactic Pregabalin for Pain in Radical Head and Neck Cancer Patients Receiving Radiotherapy
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Radiotherapy-related pain
- Sponsor
- South Eastern Sydney Local Health District
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Gender: male and female
- •Age: \>18 years
- •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
Outcomes
Primary Outcomes
Not specified
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