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Clinical Trials/ACTRN12618001794291
ACTRN12618001794291
Not yet recruiting
Phase 2

Pilot Randomised Controlled Trial of Prophylactic Pregabalin for Pain in Radical Head and Neck Cancer Patients Receiving Radiotherapy

South Eastern Sydney Local Health District0 sites30 target enrollmentNovember 2, 2018

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.

Registry
who.int
Start Date
November 2, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional
Sex
All

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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