EUCTR2013-003968-31-GB进行中（未招募）1 期
A phase II RCT of topical menthol gel versus placebo in the treatment of chemotherapy induced peripheral neuropathic pain - MINT (Menthol In Neuropathy Trial)
niversity of Edinburgh (ACCORD)0 个研究点目标入组 40 人开始时间: 2013年12月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(a) Patients have received any neurotoxic chemotherapy.
- •(b) Patients have experienced post treatment Chemotherapy Induced Peripheral Neuropathy (CIPN) pain for a minimum of 3 months after completing chemotherapy.
- •(c) Patients reporting a distressing or uncomfortable neuropathic symptom (such as pain or tingling) with an average score in the last 24 hours of =5 on a scale of 0-10 with 0 being none, according to the Numeric Rating Scale for pain.
- •(d) Aged 18 years or over at study entry.
- •(e) Patient’s Oncology team agrees to their taking part in the study.
- •(f) Patients are able to provide written informed consent to participation in the study after explanation of the study protocol.
- •(g) In the opinion of the investigator, the patient is able to complete the various assessments.
- •(h) Neuropathy must be confined to the distal extremities (distal to elbows and/or knees).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •(a) Pre-existing or history of peripheral neuropathy due to any cause other than chemotherapy (diabetes, alcohol, toxin, hereditary, etc.).
- •(b) Patients with any contraindication to the use of topical therapy or menthol.
- •(c) Neurological conditions which may influence findings (such as Multiple Sclerosis or residual signs/symptoms from a previous stroke).
- •(d) Skin conditions which prevent assessment of the relevant areas affected by peripheral neuropathy.
- •(e) Suffering from significant psychiatric illness, which would hinder their completion of the study in the opinion of the investigator.
- •(f) General medical condition is unstable or rapidly deteriorating, such that they are unlikely to be able to contribute to the study.
- •(g) In the opinion of the Research Team or their usual medical team, would be unable to complete the study protocol for any other reason.
- •(h) Current treatment of = 30 days duration with anticonvulsants, tricyclic antidepressants, MAO inhibitor, or other neuropathic pain medication agents such as carbamazepine, phenytoin, valproic acid, gabapentin/pregabalin, lamotrigine or amifostine. (If on the same dose of any of these medications for >31 days, patients will be asked to continue these for the duration of the study. Analgesic agents such as acetaminophen, nonsteroidal anti-inflammatory agents, or opioids, are allowed if on the same doses for >31 days).
- •(i) Application of topical lidocaine patch/gel or capsaicin cream or patch (to the limb extremities) currently or within the last 30 days (as this would interfere with application of the menthol gel and potentially study outcome).
- •(j) Patients with significant pain other than CIPN (ie pain worse than the CIPN).
- •(k) Patients with a pain that is likely to emerge during the scan because of position.
- •(l) Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient.
- •(m) Contraindication to MRI: e.g. aneurysm clips, pacemaker, other metal work in body, claustrophobia.
- •(n) Participants previously randomised into this study.
- •(o) Participants not prepared to stop using any other physical activity meter.
- •(p) Co-enrolment in any other pain treatment studies.
研究者
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