Effectiveness and Cost-effectiveness of Ozone Treatment in Patients with Paresthesia (numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy. Randomized, Triple-blind Clinical Trial (OzoParQT)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change from baseline in "numbness and tingling" self-perceived by patients at the end of follow-up (week 28 after the commencement of ozone treatment)
研究概览
简要总结
The goal of this phase II/III randomized clinical trial is to evaluate the effect of adding rectal ozone therapy to the usual management of patients with paresthesia (numbness and/or tingling) due to chemotherapy-induced peripheral neuropathy (CIPN). Ozone treatment consists of the rectal insufflation of 180 - 300 milliliters of an ozone/oxygen gas mixture.
The main questions to answer are:
- Can ozone therapy improve patients' self-perceived level of numbness and tingling?
- Can ozone therapy improve patients' self-perceived health-related quality of life (HRQoL)?
In 42 patients with chronic numbness and tingling secondary to chemotherapy, the researchers will compare:
- the addition of rectal ozone insufflations
- versus the addition of rectal oxygen insufflations (placebo). Participants will receive 40 rectal gas (ozone versus oxygen) insufflations in 16 weeks and will continue other symptomatic or cancer treatments prescribed by their oncologists.
Before treatment, after treatment, and 12 weeks after treatment, they will be evaluated:
- Several questionnaires about neuropathy, quality of life, and anxiety and depression.
- Biochemical parameters of oxidative stress and inflammation
- Hyperspectral images of hands and feet
- Toxicity of procedure.
详细描述
Rationale Chemotherapy-induced peripheral neuropathy (CIPN) can lead to a decrease and/or interruption of chemotherapy treatment, limiting its efficacy and decreasing patients' quality of life. Therapeutic measures for CIPN are very limited in number and efficacy. Our previous experience has suggested the potential clinical usefulness of adjuvant treatment with ozone in patients with CIPN. The hypothesis of the trial is that ozone treatment will improve numbness and tingling symptoms in patients with CIPN.
Primary objectives:
To evaluate the effect of adding ozone to the usual management of patients with paresthesia (numbness and/or tingling) due to chemotherapy-induced peripheral neuropathy (CIPN), Grade 2 (moderate symptoms and/or limitation in instrumental activities of daily living) or higher, on:
- patients' self-perceived level of paresthesia
- patients' self-perceived health-related quality of life (HRQoL).
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
- the oncologists/hematologists who treat and follow the patient regularly,
- researchers who carry out biochemical determinations or functional tests,
- the staff who obtain the economic data,
- statisticians
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
- •Adults > = 18 years old.
- •Previous treatment with any chemotherapy because of any tumor.
- •Clinical diagnosis of paresthesia (numbness, tingling) secondary to CIPN, with toxicity Grade > = 2 (according to the Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute of EEUU, v.5.0) for > = 3 months.
- •Without neurotoxic chemotherapy > = 3 months.
- •Cancer disease is stable or in remission.
- •Life expectancy > = 6 months.
- •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 14 days before the first ozone therapy session up to 14 days after the last one.
- •To sign and date the study-specific informed consent
排除标准
- •Age < 18 years.
- •A woman who is lactating, pregnant, suspected of being pregnant, or a woman of childbearing potential who does not use adequate contraceptive methods.
- •Suspected symptoms are due to diabetic or compressive neuropathy.
- •Severe psychiatric disorders.
- •Inability to complete the quality of life questionnaires.
- •Elevation above 5 times the maximum limit of normal creatinine.
- •Patient who is hemodynamic or clinically unstable or who requires urgent or short-term interventional measures.
- •Neoplasia in progression requiring recent initiation of systemic treatment or maintenance with neurotoxic chemotherapy.
- •Life expectancy (for any reason) < 6 months.
- •Known allergy to ozone, known glucose 6 phosphate dehydrogenase (G6PD) deficiency, or hemochromatosis.
- •Contraindications or impossibility for rectal ozone treatment or to attend regularly to the treatment.
- •Not meeting each and every one of the inclusion criteria
研究组 & 干预措施
Ozone Group
Drug: Ozone (O3/O2). Treatment: Usual treatment + Ozone therapy by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.
干预措施: Ozone therapy (Drug)
Oxygen Group (Placebo)
Drug: Oxygen (O2). Treatment: Usual treatment + Oxygen by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.
干预措施: Oxygen (placebo) (Drug)
结局指标
主要结局
Change from baseline in "numbness and tingling" self-perceived by patients at the end of follow-up (week 28 after the commencement of ozone treatment)
时间窗: 28 weeks
Self-reported evaluation of the percentage of "numbness and/or tingling" regarding the basal level. From 100% (basal level, 0% improvement) to 0% (no numbness and tingling, 100% improvement).
Change from Baseline in quality of life by the EQ-...
时间窗: 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 an extreme problem or I am unable to...) and b) additional self-assessment of health by a visual analog scale (0 = worst health patient can imagine, 100 = best health patient can imagine).
次要结局
- Direct hospital costs(28 weeks)
- Change from baseline in "numbness and tingling" self-perceived by patients at the end of ozone treatment.(16)
- Changes from baseline in the Grade of toxicity of parestesias (numbness, tingling) according to the CTCAE v.5.0. scale at the end of ozone treatment.(16 weeks)
- Changes from baseline in the Grade of toxicity of sensory neuropathy according to the CTCAE v.5.0. scale at the end of ozone treatment.(16 weeks.)
- Changes from baseline in the degree of neuropathy according to the QLQ-CIPN20 scale at the end of ozone treatment.(16 weeks.)
- Change from baseline in "Quality of Life" (using the EQ-5D-5L questionnaire) self-perceived by patients at the end of ozone treatment (week 16 after the commencement of ozone treatment).(16 weeks.)
- Changes from baseline in the "Quality of Life" according to the QLQ-C30 questionnaire at the end of ozone treatment.(16 weeks.)
- Changes from baseline in levels of anxiety and depression according to the Hospital Anxiety and Depression Scale (HADS), at the end of ozone treatment.(16 weeks)
- Changes from baseline in biochemical parameters of oxidative stress at the end of ozone treatment.(16 weeks.)
- Changes from baseline in biochemical parameters of inflammation at the end of ozone treatment.(16 weeks)
- Changes from baseline in Hyperspectral signatures and infrared images obtained from hands and feet at then of ozone treatment.(16 weeks)
- Changes from baseline in the Grade of toxicity of paresthesias (numbness, tingling) according to the CTCAE v.5.0. scale at the end of follow-up.(28 weeks.)
- Changes from baseline in the Grade of toxicity of sensory neuropathy according to the CTCAE v.5.0. scale at the end of follow-up.(28 weeks)
- Changes from baseline in the degree of neuropathy according to the QLQ-CIPN20 scale at the end of follow-up.(Time frame: 28 weeks)
- Changes from baseline in the "Quality of Life" according to the QLQ-C30 questionnaire at the end of follow-up.(28 weeks.)
- Changes from baseline in levels of anxiety and depression according to the Hospital Anxiety and Depression Scale (HADS) at the end of follow-up.(28 weeks.)
- Changes from baseline in biochemical parameters of oxidative stress at the end of follow-up.(28 weeks.)
- Changes from baseline in biochemical parameters of inflammation at the end of follow-up.(28 weeks.)
- Changes from baseline in Hyperspectral signatures and infrared images obtained from hands and feet at the end of follow-up.(28 weeks.)
- Toxicity of rectal ozone treatment at the end of follow-up.(28 weeks.)
研究者
Bernardino Clavo, MD, PhD
Bernardino Clavo, MD, PhD, Dr. Negrin University Hospital
Dr. Negrin University Hospital