A randomized trial of topical menthol for chemotherapy induced neuropathy

局部薄荷醇治疗化疗引起的神经病变的随机试验

• 批准号: 8759581
• 负责人: DAWN HERSHMAN
• 金额: $ 6.96万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8759581
• 关键词: Address; Adjuvant; Adjuvant Chemotherapy; Adjuvant Therapy; Adverse effects; Affect; Aftercare; Alcohols; Analgesics; Anticonvulsants; Antidepressive Agents; Antineoplastic Agents; Area; Brief Pain Inventory; Cancer Patient; Cancer Survivor; Colon Carcinoma; Colorectal Cancer; Complication; Distal; Double-Blind Method; Drug Interactions; Early Diagnosis; Early treatment; European Organization for Research and Treatment of Cancer; Family; Hand; Hour; Intervention; Ions; Joints; Lead; Life; Long-Term Effects; Lotion; Measures; Menthol; Motor; Musculoskeletal; Narcotic Analgesics; Neurologic; Neuropathy; One-Step dentin bonding system; Pain; Patients; Peripheral Nervous System Diseases; Pharmaceutical Preparations; Pilot Projects; Placebo Control; Placebos; Plants; Platinum Compounds; Positioning Attribute; Pruritus; Quality of life; Randomized; Regimen; Reporting; Research; Risk; Sensory; Symptoms; Taxane Compound; Tendon structure; Terpenes; Testing; Time; Topical agent; Toxic effect; United States; arm; base; cancer therapy; chemotherapy; chemotherapy induced neuropathy; cost; foot; improved; malignant breast neoplasm; neurotoxicity; non-opioid analgesic; oxaliplatin; painful neuropathy; phase 1 study; prevent; public health relevance; randomized trial; receptor; sensory neuropathy; taxane; vibration

DESCRIPTION (provided by applicant): Due to major advances in early detection and therapy, an estimated 12 million cancer survivors are living in the United States today. Unfortunately, most cancer therapies are known to carry a substantial risk of adverse long-term effects. One of the most common and debilitating adverse effects is chemotherapy-induced peripheral neuropathy (CIPN), which is associated with many widely used anticancer drugs. The optimal treatment for persistent CIPN remains unknown. Symptomatic treatments include antidepressants, anticonvulsants, non-narcotic and narcotic analgesics. While antidepressants have shown moderate benefit, their use has been limited due to side effects and significant drug to drug interactions. A few small unblinded studies of topical menthol suggest a possible benefit in relieving neuropathy. We hypothesize that six week treatment with 2% topical Menthol application twice a day will decrease persistent neuropathic pain following adjuvant chemotherapy with a Taxane or Oxaliplatin-based regimen. We plan to test this hypothesis with a two arm double blind, placebo controlled, randomized pilot study following adjuvant therapy in breast and colon cancer patients. Our aims are (1) To assess whether six week treatment with twice daily topical Menthol application will decrease persistent neuropathic pain; (2) To evaluate the effect of topical Menthol compared to placebo on global measures of neuropathy; (3) To evaluate the effect of topical Menthol on objective sensory and motor functional tests; and (4) To perform an exploratory analysis evaluating the interaction between treatment and chemotherapy type. To date, we have not been successful at treating or preventing CIPN. This study evaluates the use of a promising and readily available, low cost and well tolerated topical intervention. If found beneficial, this treatment addressing the putative underlying mechanism of CIPN, may bring us one step closer to improving the lives of cancer survivors.

描述（由申请人提供）：由于早期检测和治疗方面的重大进步，目前美国估计有 1200 万癌症幸存者。不幸的是，已知大多数癌症疗法都存在产生长期不良影响的巨大风险。最常见且令人衰弱的不良反应之一是化疗引起的周围神经病变（CIPN），它与许多广泛使用的抗癌药物有关。持续性 CIPN 的最佳治疗方法仍然未知。对症治疗包括抗抑郁药、抗惊厥药、非麻醉性和麻醉性镇痛药。虽然抗抑郁药显示出一定的疗效，但由于副作用和显着的药物间相互作用，其使用受到限制。一些关于局部薄荷醇的小型非盲研究表明，薄荷醇可能有助于缓解神经病变。我们假设每天两次局部使用 2% 薄荷醇进行为期六周的治疗，将减少紫杉烷或奥沙利铂辅助化疗后的持续性神经性疼痛。我们计划在乳腺癌和结肠癌患者接受辅助治疗后，通过一项双臂双盲、安慰剂对照、随机试点研究来检验这一假设。我们的目标是（1）评估每天两次局部使用薄荷醇进行六周治疗是否会减轻持续性神经性疼痛； (2) 评估局部薄荷醇与安慰剂相比对神经病变总体指标的影响； (3) 评价外用薄荷醇对客观感觉和运动功能测试的影响； (4) 进行探索性分析，评估治疗与化疗类型之间的相互作用。迄今为止，我们在治疗或预防 CIPN 方面尚未成功。本研究评估了一种有前途且易于获得、成本低廉且耐受性良好的局部干预措施的使用。如果发现这种治疗方法有益，那么它可以解决 CIPN 的潜在机制，可能会让我们在改善癌症幸存者的生活方面更近一步。