TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Feasibility of a 12 month trial investigating the use of pravastatin to treat radiation-associated dysphagia
研究概览
简要总结
The aim of this trial is to examine the feasibility, acceptability, and potential efficacy of a 12-month course of pravastatin as an antifibrotic agent for managing dysphagia (swallowing problems) in patients previously treated with radiotherapy for head and neck cancer (HNC). The purpose is to assess whether pravastatin, a medication approved in Australia for cholesterol management, can improve swallowing in people with long-term radiation-associated dysphagia following HNC treatment.
The trial will recruit 48 patients, with an anticipated accrual period of approximately 6 months. Eligible patients will be identified from the Principal Investigator's current study, ERADICATE, or through referral by a radiation oncologist or speech pathologist diagnosing radiation-induced dysphagia.
Participants will receive 40 mg of pravastatin daily for up to 12 months, with swallowing assessments conducted before, during, and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has provided written informed consent using the TRADstat PICF
- •Patients aged 18 years or older at screening
- •Received curative intent (chemo)radiotherapy to the nasopharynx, oropharynx, hypopharynx or larynx at least 2 years prior to screening
- •Moderate-severe RAD using validated cut-offs (PAS score > 3 and/or DIGEST grading ≥ 2), identified on a VFSS conducted within the last 12 months
- •Adequate kidney function defined as estimated glomerular filtration rate (eGFR) ≥ 40 ml/min
- •Adequate hepatic function defined as:
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than 2 times the upper normal limit (ULN)
- •Bilirubin level at least 1.5 times lower than the ULN
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (Appendix 1)
排除标准
- •Known hypersensitivity to pravastatin and/or any excipients
- •Diagnosis of myasthenia (muscle weakness)
- •History of head or neck surgery, other than excisional biopsy or post treatment neck dissection
- •Known active malignancy
- •Currently taking statin medication
- •Currently taking prohibited medicines (long-term steroids or drugs listed under Section 8.4)
- •History of severe heart failure; a history of muscle toxicity during previous treatments with fibrates or statins; a history of hereditary muscle diseases
- •Known medical condition(s) that may impact swallowing function (e.g., stroke, neurological conditions, tracheostomy)
- •Pregnant or breastfeeding
研究组 & 干预措施
Single arm study
Single arm study
干预措施: Pravastatin 40 Mg Oral Tablet (Drug)
结局指标
主要结局
Feasibility of a 12 month trial investigating the use of pravastatin to treat radiation-associated dysphagia
时间窗: From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)
Percentage of eligible patients who consent to recruitment and percentage of recruited (registered) patients who remain on pravastatin for 12 months and complete the 6-month follow-up assessment
Preliminary evidence of efficacy of the pravastatin to treat radiation-associated dysphagia
时间窗: From enrolment to the end of 12 months of pravastatin use
A Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade decrease of at least 1-point after 12 months of pravastatin from registration. The DIGEST scale ranges between 0 to 4, with 4 being the worst outcome.
次要结局
- Acceptability of trial methods and procedures and acceptability of pravastatin(From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months))
- Tolerability of pravastatin(From the start of pravastatin therapy until the completion of 12 months of therapy)
- Safety of pravastatin use(From the start of pravastatin therapy until the completion of 12 months of therapy)