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臭氧治疗化疗引起的周围神经病变：RCT (O3NPIQ) (O3NPIQ)

2026年9月22日 更新者：Bernardino Clavo, MD, PhD

臭氧疗法对化疗引起的周围神经病变继发疼痛患者的有效性和成本效益。随机、三盲临床试验 (O3NPIQ)

The main objective of this clinical trial is to evaluate the effectiveness and cost-effectiveness of adding ozone therapy to the clinical management of patients with pain secondary to chemotherapy-induced peripheral neuropathy

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Chemotherapy-induced peripheral neuropathy (CIPN) decreases the quality of life of patients and can lead to a decrease and/or interruption of the chemotherapy treatment-limiting its effectiveness. The therapeutic measures for the CIPN are very limited in their number and efficacy.

Main Objectives: 1) To evaluate the clinical effect on the health-related quality of life (HRQOL) of adding ozone to the usual patient´s treatment with persistent pain because of CIPN. 2) Estimate the additional costs and evaluate the cost-effectiveness ratio.

Secondary Objectives: To evaluate the evolution of 3) oxidative stress and chronic inflammation through biochemical measurements; 4) anxiety and depression of patients; 5) the diagnostic and predictive value of hyperspectral imaging in the assessment of pain; 6) the acceptability of patients to a shared decision-making (SDM) tool.

METHODOLOGY: Randomized controlled trial (RCT) phase II-III, randomized, triple-blind; 42 patients with any kind of cancer treated with any kind of chemotherapy, with CIPN of grade > = 2 for > = 3 months.

TREATMENT: All patients will receive: usual treatment + 40 rectal insufflation sessions of O3/O2 in 16 weeks:

  • Ozone-Arm (n = 21): concentration of O3/O2 increasing from 10 to 30 μg/ml.
  • Control-placebo- Arm (n = 21): concentration of O3/O2 = 0 μg/ml.

Main Variables: At the end of treatment with O3/O2 the following variables will be analyzed: 1) "average pain" secondary to CIPN following the Brief Pain Inventory-Short Form (BPI-SF); 2) health-related quality of life (HRQOL) and utilities using EQ-5D-5L and SF-36 quality of life questionnaires; 3) Direct costs.

Secondary Variables: 3) biochemical parameters of oxidative stress and inflammation; 4) Hamilton scale for anxiety and depression; 5) hyperspectral images; 6) acceptability of patients to a shared decision-making (SDM) tool.

Assessments at weeks: 0 (baseline), 16 (end of O3/O2 insufflations, objective), and 28 (end of follow-up, control).

Length of treatment: 16 weeks.

Follow-up: 12 weeks after finishing O3/O2 insufflation.

Planned length of the clinical trial: 36 months.

研究类型

介入性

注册 (估计的)

42

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 西班牙
    • Las Palmas
      • Las Palmas de Gran Canaria、Las Palmas、西班牙、35016
        • 招聘中
        • Complejo Hospitalario Materno Insular
        • 接触：
      • Las Palmas de Gran Canaria、Las Palmas、西班牙、35019
        • 招聘中
        • Hospital Universitario de Gran Canaria Dr. Negrín
        • 接触：
        • 副研究员：
          • Saray Galván, MD
        • 副研究员：
          • Francisco Rodríguez-Esparragón, BSc, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 1. Adults > = 18 years old.
  • 2. Any kind of cancer in any stage, treated with any kind of chemotherapy, and life expectancy > = 6 months.
  • 3. Clinical diagnosis of painful chemotherapy-induced peripheral neuropathy, toxicity Grade 2 or higher according to the Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute of EEUU, v.5.0, for > = 3 months and without the inclusion of new treatments for pain and/or neuropathy for > = 1 month.
  • 4. "Average pain" > = 3/10 according to the Brief Pain Inventory-Short Form (BPI-SF) > = 3 months beyond chemotherapy completion.
  • 5. Pregnant women cannot participate in the clinical trial.
  • 6. Before enrollment, women of childbearing potential should obtain a negative result in the serum or urine pregnancy test at the screening visit and accept the use of appropriate contraceptive methods at least from the 14 days prior to the first ozone therapy session up to 14 days after the last one.
  • 7. Patients who have signed and dated the study 's specific informed consent

Exclusion Criteria:

  • 1. Age < 18 years old.
  • 2. Pregnancy at the time of enrollment.
  • 3. Women with childbearing potential who are unwilling to perform a pregnancy test and/or employ adequate contraception from the 14 days prior to the first ozone therapy session up to 14 days after the last one.
  • 4. Clinical suspicion that peripheral neuropathy (compressive or diabetic neuropathy) in the same area prior to receiving neurotoxic chemotherapy.
  • 5. Psychiatric illness or social situations that would limit compliance with study requirements.
  • 6. Those who are unable to fill in the scales used to measure quality of life variables
  • 7. Specific liver enzymes [Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) > 5 times the upper limit of normal
  • 8. Increased creatinine > 3 times the upper limit of normal.
  • 9. Hemodynamically or clinically unstable patients or uncontrolled severe illness.
  • 10. Uncontrolled cancer disease.
  • 11. Leptomeningeal carcinomatosis.
  • 12. Life expectancy < 6 months
  • 13. Contraindication or disability for rectal ozone administration or to attend scheduled treatments.
  • 14. Known allergy to ozone.
  • 15.Patients who do not meet all the inclusion criteria.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Ozone Group

Drug: Ozone Ozone Group: Usual treatment + Ozone therapy (O3/O2) by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.

Other Names: O3
药品：Ozone

Ozone Group: Standard treatment + Ozone therapy (O3/O2) by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.

其他名称：
  • O3
安慰剂比较：Control Group

Drug: Oxygen Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.

Other Names: O2
药品：Oxygen

Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.

其他名称：
  • 氧气

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change from Baseline in "Average pain" according to the Brief Pain Inventory-Short Form (BPI-SF) (at the end of ozone therapy)
大体时间：16 weeks

Self-reported evaluation of 15 items to assess the severity of pain on daily functions in seven interference areas. From the 15 items, 11 items are scored from 0 ("No pain" or "Does not no interfere") to 10 ("Pain as bad as you can imagine" or "Completely interferes").
16 weeks
Direct Hospital Cost (at the end of ozone therapy)
大体时间：16 weeks

The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 16 weeks of ozone therapy (in euros).
16 weeks

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline in quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at the end of ozone therapy)
大体时间：16 weeks

Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
16 weeks
Change from Baseline in quality of life by the "Short Form 36-item health survey" (SF-36v2) questionnaire (at the end of ozone therapy)
大体时间：16 weeks

Self-reported evaluation of 36 items (0 = worst, 100 = best). Final accumulated total range from 0 (worst) to 100 (best)
16 weeks
Change from Baseline in Biochemical parameters of oxidative stress (at the end of ozone therapy)
大体时间：16 weeks

Serum levels of superoxide dismutase, glutathione, glutathione peroxidase and free radicals
16 weeks
Change from Baseline in Biochemical parameters of inflammation (at the end of ozone therapy)
大体时间：16 weeks

Serum levels of pro-inflammatory interleukins and TNFalpha
16 weeks
Change from Baseline in Hyperspectral image of painful area (at the end of ozone therapy)
大体时间：16 weeks

Assessment of the percentage of reflectance for each wavelength
16 weeks
Change from Baseline in Levels of anxiety and depression according to the Hamilton scale (at the end of ozone therapy)
大体时间：16 weeks

Clinician-administered depression assessment scale with 17 items pertaining to symptoms of depression experienced over the past week. Each item is scored from 0 (better, no alteration) to 2 (worse level of alteration) for items with three options, or from or from 0 (better, no alteration) to 4 (worse level of alteration) for items with five options. Overall score is from 0 (better, no anxiety/depression) to 52 (worse, very severe anxiety/depression).
16 weeks
Change from Baseline in Nerve conduction studies in the painful area (at the end of ozone therapy)
大体时间：16 weeks

Assessment of nerve conduction velocity (in m/s)
16 weeks
Incidence of severe adverse events in accordance with the definition of the Council for International Organizations of Medical Sciences (at the end of ozone therapy)
大体时间：16 weeks

Number of events that are fatal, life threatening, leading to or prolonging a stay in hospital, or resulting in severe disability
16 weeks
Change from Baseline in "Average pain" according to the Brief Pain Inventory-Short Form (BPI-SF) (at 12 weeks after the end of ozone therapy)
大体时间：28 weeks

Self-reported evaluation of 15 items to assess the severity of pain on daily functions in seven interference areas. From the 15 items, 11 items are scored from 0 ("No pain" or "Does not no interfere") to 10 ("Pain as bad as you can imagine" or "Completely interferes")
28 weeks
Direct Hospital Cost (at 12 weeks after the end of ozone therapy)
大体时间：28 weeks

The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 16 weeks of ozone therapy (in euros)
28 weeks
Change from Baseline in quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at 12 weeks after the end of ozone therapy)
大体时间：28 weeks

Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
28 weeks
Change from Baseline in quality of life by the "Short Form 36-item health survey" (SF-36v2) questionnaire (at 12 weeks after the end of ozone therapy)
大体时间：28 weeks

Self-reported evaluation of 36 items (0 = worst, 100 = best). Final accumulated total range from 0 (worst) to 100 (best)
28 weeks
Change from Baseline in Biochemical parameters of oxidative stress (at 12 weeks after the end of ozone therapy)
大体时间：28 weeks

Serum levels of superoxide dismutase, glutathione, glutathione peroxidase and free radicals
28 weeks
Change from Baseline in Biochemical parameters of inflammation (at 12 weeks after the end of ozone therapy)
大体时间：28 weeks

Serum levels of pro-inflammatory interleukins and TNFalpha
28 weeks
Change from Baseline in Hyperspectral image of painful area (at 12 weeks after the end of ozone therapy)
大体时间：28 weeks

Assessment of the percentage of reflectance for each wavelength
28 weeks
Change from Baseline in Levels of anxiety and depression according to the Hamilton scale (at 12 weeks after the end of ozone therapy)
大体时间：28 weeks

Clinician-administered depression assessment scale with 17 items pertaining to symptoms of depression experienced over the past week. Each item is scored from 0 (better, no alteration) to 2 (worse level of alteration) for items with three options, or from or from 0 (better, no alteration) to 4 (worse level of alteration) for items with five options. Overall score is from 0 (better, no anxiety/depression) to 52 (worse, very severe anxiety/depression)
28 weeks
Change from Baseline in Nerve conduction studies in the painful area (at 12 weeks after the end of ozone therapy)
大体时间：28 weeks

Assessment of nerve conduction velocity (in m/s)
28 weeks
Incidence of severe adverse events in accordance with the definition of the Council for International Organizations of Medical Sciences (at 12 weeks after the end of ozone therapy)
大体时间：28 weeks

Number of events that are fatal, life threatening, leading to or prolonging a stay in hospital, or resulting in severe disability
28 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bernardino Clavo, MD, PhD

合作者

Servicio Canario de Salud
Instituto de Salud Carlos III
Red de Investigación en Servicios de Salud en Enfermedades Crónicas
Fundación DISA, Spain
Fundación Española del Dolor (FED)
Council of Gran Canaria

调查人员

  • 学习椅：Bernardino Clavo, MD, PhD、Dr. Negrín University Hospital, Las Palmas, Spain
  • 研究主任：Pedro G Serrano-Aguilar, MD, PhD、Servicio de Evaluación. Servicio Canario de Salud. Spain
  • 首席研究员：Delvys Rodríguez-Abreu, MD、Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas, Spain
  • 首席研究员：Gustavo M Callico, Prof, PhD、Institute for Applied Microelectronics, University of Las Palmas de G. C., Spain
  • 首席研究员：Francisco Rodríguez-Esparragón, BSc, PhD、Dr. Negrín University Hospital, Las Palmas, Spain
  • 首席研究员：Bernardino Clavo, MD, PhD、Dr. Negrín University Hospital, Las Palmas, Spain

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年11月30日

初级完成 (估计的)

2027年9月30日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2020年3月5日

首先提交符合 QC 标准的

2020年3月6日

首次发布 (实际的)

2020年3月9日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月22日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2018-156-1
  • PI 19/00458 (其他赠款/资助编号：Instituto de Salud Carlos III)
  • 016/2019 (其他赠款/资助编号：Fundación DISA)
  • BF1-19-03 (其他赠款/资助编号：Fundación Española del Dolor (FED))
  • 2019 (美国 NIH 拨款/合同)
  • 2019-000821-37 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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