ACTRN12618001794291尚未招募2 期
Pilot Randomised Controlled Trial of Prophylactic Pregabalin for Pain in Radical Head and Neck Cancer Patients Receiving Radiotherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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