ISRCTN69917256已完成未知
sing functional magnetic resonance imaging to investigate the efficacy of menthol in chemotherapy induced peripheral neuropathy (CIPN): a pilot exploratory study
Academic and Clinical Centre Office for Research and Development (ACCORD) (UK)0 个研究点目标入组 32 人开始时间: 2013年9月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients have received any neurotoxic chemotherapy.
- •2. Patients have experienced post treatment chemotherapy induced peripheral neuropathy (CIPN) pain for a minimum of 3 months.?
- •3. Patients reporting a distressing or uncomfortable neuropathic symptom (such as pain or tingling) with a score of =4 on a scale of 0-10 with 0 being none.
- •4. Male and female aged 18 years or over at study entry.
- •5. Patient?s Oncology team agrees to their taking part in the study.
- •6. Patients are able to provide written informed consent to participation in the study after explanation of the study protocol.
- •7. Patients have the ability to complete questionnaire assessments in English language.
- •8. In the opinion of the investigator, the patient is able to complete the various assessments.
- •9. Neuropathy must be confined to the distal extremities (distal to elbows and/or knees).
排除标准
- •1. Preexisting or history of peripheral neuropathy due to any cause other than chemotherapy (diabetes, alcohol, toxin, hereditary, etc).?
- •2. Patients with any contraindication to the use of topical therapy or menthol.
- •3. Neurological conditions which may influence findings (such as multiple sclerosis or residual signs/symptoms from a previous stroke).
- •4. Skin conditions which prevent assessment of the relevant areas affected by peripheral neuropathy.
- •5. Suffering from significant psychiatric illness, which would hinder their completion of the study.
- •6. General medical condition is unstable or rapidly deteriorating, such that they are unlikely to be able to contribute to the study.
- •7. In the opinion of the Research Team or their usual medical team, would be unable to complete the study protocol for any other reason.
- •8. Current treatment of = 30 days duration with anticonvulsants, tricyclic antidepressants, monoamine oxidase (MAO) inhibitor, or other neuropathic pain medication agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine or amifostine. (If on a stable 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).
- •9. 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 cream and potentially study outcome).
- •10. Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient.
- •11. Contraindication to magnetic resonance imaging (MRI): e.g. aneurysm clips, other metal work in body, claustrophobia.
研究者
相似试验
已完成
不适用
The study of functional magnetic resonance imaging for the evaluation of the neural basis of the symptoms and state of mental illness.healthy volunteer schizophrenia mood disorders neurotic disorders disorders of psychological development behavioural and emotional disordersJPRN-UMIN000010716ippon Medical School180
尚未招募
不适用
Functional magnetic resonance Imaging GUided Radiation therapy dose Escalation in Head and Neck Cancer (FIGURE-rad HNC)ACTRN12620000534987Dr Myo Min30
招募中
1 期
Based on functional magnetic resonance imaging (fMRI) to explore the mechanism of acupuncture in uterine acupoint in the treatment of reproductive system diseasesReproductive diseaseITMCTR2100004982Shandong Provincial Third Hospital
尚未招募
不适用
Effect of bone tunnel position on outcome of anterior cruciate ligament reconstructioCTRI/2021/09/036470Dept of Orthopaedics
已完成
不适用
Resting State functional magnetic resonance imaging of human brain responses to nutrient shakes.Feeding behaviorResponse to feeding10003018NL-OMON43766nilever20