临床试验/NCT06744816

NCT06744816招募中1 期

Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study

M.D. Anderson Cancer Center1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2025年12月11日最近更新: 2026年6月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: M.D. Anderson Cancer Center
入组人数: 20
试验地点: 1
主要终点: Safety and adverse events (AE)s

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients.

详细描述

Primary Objectives

• To assess changes in Gait (specifically looking at velocity) before and after use of topical capsaicin.

Secondary Objectives

To assess Pain intensity numerical rating scale (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of capsaicin 8% topical patch.
To assess changes in quantitative sensory testing (QST) before and after use of topical capsaicin.
To assess skin punch biopsy to compare the integrity of epidermal nerve fibers and Meissner's corpuscles (MC) in CIPN patients before and after use of topical capsaicin (optional).
To assess pain tumor related neuropathy assessment scale (TNAS) before and after topical capsaicin
To assess pain interference using the Brief Pain Inventory (BPI), before and after topical capsaicin
To assess Patient Global Impression of Change (PGIC)
To assess the rate of adverse events and tolerability of topical capsaicin as reported by participants

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Supportive Care
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

•Participants diagnosed with pain of the lower extremity from chronic (>90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds), seen at MD Anderson Cancer Center
•Participants reporting baseline pain ≥ 4 (0-10 scale, NRS)
•Participants age 18+
•Participants who have completed chemotherapy within the last year at the time of enrollment.

排除标准

•Participants with cognitive dysfunction
•Participants with recent history (<6 months) of drug or alcohol abuse
•Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection
•Participants with allergies to capsaicin or adhesives
•Pregnant participants

研究组 & 干预措施

Treatment with Qutenza Patch (Topical Capsaicin)

Experimental

Up to 4 topical capsaicin patches will be applied on your feet for 30 minutes.

干预措施: Qutenza Patch (Drug)

结局指标

主要结局

Safety and adverse events (AE)s

时间窗: Through study completion; an average of 1 year

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

次要结局

未报告次要终点

研究者

发起方

M.D. Anderson Cancer Center

申办方类型

Other

责任方

Sponsor

研究点 (1)

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