Prospective and Observational Study of Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2026 and 2029. Prospective Study EPOOzo-2.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from Baseline in Health-Related Quality of Life by the "EQ-5D-5L" Questionnaire (at the end of ozone therapy).
研究概览
简要总结
The main objective of this study is to analyze the impact on the health-related quality of life of patients with refractory symptoms who have been referred to the Dr. Negrín University Hospital Chronic Pain Unit for adjuvant palliative treatment with ozone therapy between January 2026 and December 2029. Additionally, the study aims to evaluate several specific symptoms, hyperspectral and thermal images, non-invasive clinical parameters related to the Autonomic Nervous System (such as heart rate variability, electrochemical skin conductance, and vibration perception thresholds), oxidative stress and inflammatory parameters, and gut microbiota composition.
详细描述
Patients are referred to the Chronic Pain Unit in the absence or failure of standard treatment, or when the standard treatment is associated with high morbidity or high risk. Frequently, these patients present alterations in self-perceived health-related quality of life (HRQoL), anxiety, depression, and other symptoms such as radiation-induced pelvic toxicity or chemotherapy-induced peripheral neuropathy (CIPN).
This prospective observational study (EPOOzo-2) aims to evaluate the effect of adjuvant symptomatic/palliative ozone therapy on HRQoL and potential changes from baseline. Specifically, it incorporates new non-invasive technologies to objectively assess microcirculation, neuropathy and autonomic regulation.
Main Objectives:
1. Analyze the impact on HRQoL of patients with refractory symptoms treated with ozone.
Secondary Objectives: Depending on the clinical case, analyze the impact of ozone treatment on: 2. Anxiety and depression. 3. Treated symptoms (e.g., pain, paresthesia). 4. Fatigue. 5. Toxicity grade (in cancer patients). 6. Non-invasive clinical parameters related to the Autonomic Nervous System (central and peripheral) and somatosensory function. 7. Biochemical parameters and gut microbiome analysis (in patients with systemic/rectal ozone).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •1. Adults ≥ 18 years old.
- •2. Patients referred to the Chronic Pain Unit of the Dr. Negrín University Hospital for symptomatic/palliative treatment with ozone therapy because conventional treatment does not exist, has failed, has offered insufficient results, or is associated with high risk/morbidity.
- •3. After evaluation of symptoms and patients, it exists a potential benefit of adding ozone treatment to the current treatment.
- •4. Patients have no contraindications for ozone treatment.
- •5. Patients must sign the specific Informed Consent for this study and for the ozone treatment.
排除标准
- •1. Age < 18 years old.
- •2. Psychiatric illness or social situations that would limit compliance with study requirements.
- •Contraindication or disability to attend scheduled treatments.
- •3. Contraindication or disability to attend scheduled treatments.
- •4. Uncontrolled clinical conditions (e.g., severe heart failure, massive hemorrhage, status epilepticus).
- •5. Life expectancy < 6 months.
- •6. Known allergy to ozone.
- •7. Hemochromatosis (for systemic ozone treatment).
- •8. Pregnancy (for systemic ozone treatment).
- •9. Significant Glucose-6-Phosphate Dehydrogenase deficiency (Favism) (for systemic ozone treatment).
- •10. Patients who do not meet the inclusion criteria.
结局指标
主要结局
Change from Baseline in Health-Related Quality of Life by the "EQ-5D-5L" Questionnaire (at the end of ozone therapy).
时间窗: At the end of ozone therapy (approx. week 16).
Self-reported evaluation of 5 physical and emotional items scored in five levels, plus a Visual Analog Scale (EQ-VAS) from 0 (worst health) to 100 (best health).
次要结局
- Change from Baseline in Health-Related Quality of Life by the "QLQ-C30" Questionnaire (only in cancer patients). (At 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Change from Baseline in Health-Related Quality of Life by the "QLQ-C30" Questionnaire (only in cancer patients). (At 24 weeks after the end of ozone therapy).(At 24 weeks after the end of ozone therapy (approx. week 40).)
- Change from Baseline in Fatigue (Chalder Fatigue Scale and/or EORTC QLQ-FA12 for cancer patients) (at the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
- Change from Baseline in Fatigue (Chalder Fatigue Scale and/or EORTC QLQ-FA12 for cancer patients) (at 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Change from Baseline in Fatigue (Chalder Fatigue Scale and/or EORTC QLQ-FA12 for cancer patients) (at 24 weeks after the end of ozone therapy).(At 24 weeks after the end of ozone therapy (approx. week 40).)
- Change from Baseline in Pain Score (Visual Analog Scale), (at the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
- Change from Baseline in Pain Score (Visual Analog Scale), (at 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Change from Baseline in Pain Score (Visual Analog Scale), (at 24 weeks after the end of ozone therapy).(At 24 weeks after the end of ozone therapy (approx. week 40).)
- Change from Baseline in the grade of toxicity secondary to cancer-treatment (if applicable) according to the CTCAE v5.0 scale, (at the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
- Change from Baseline in the grade of toxicity secondary to cancer-treatment (if applicable) according to the CTCAE v5.0 scale, (at 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Change from Baseline in the grade of toxicity secondary to cancer-treatment (if applicable) according to the CTCAE v5.0 scale, (at 24 weeks after the end of ozone therapy).(At 24 weeks after the end of ozone therapy (approx. week 40).)
- Change from Baseline in Electrochemical Skin Conductance (Sudoscan), (at the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
- Change from Baseline in Electrochemical Skin Conductance (Sudoscan), (at 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Change from Baseline in Vibration Perception Thresholds (Multifrequency Vibrometry), (at the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
- Change from Baseline in Vibration Perception Thresholds (Multifrequency Vibrometry), (at 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Change from Baseline in Postural Stability (Equilibrium Platform), (at the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
- Change from Baseline in Postural Stability (Equilibrium Platform), (at 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Change from Baseline in Heart Rate Variability (HRV), (at the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
- Change from Baseline in Heart Rate Variability (HRV), (at 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Changes from baseline in Hyperspectral signatures and Infrared images obtained from hands and feet at the end of follow-up, (at the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
- Changes from baseline in Hyperspectral signatures and Infrared images obtained from hands and feet at the end of follow-up, (at 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Changes from baseline in biochemical parameters of oxidative stress and inflammation (at the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
- Changes from baseline in biochemical parameters of oxidative stress and inflammation (at 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Change from Baseline in Gut Microbiota Composition (at the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
- Change from Baseline in Gut Microbiota Composition (at 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Change from Baseline in Health-Related Quality of Life by the "EQ-5D-5L" Questionnaire (at 12 weeks after the end of ozone therapy).(At 12 weeks after the end of ozone therapy (approx. week 28).)
- Change from Baseline in Health-Related Quality of Life by the "EQ-5D-5L" Questionnaire (at 24 weeks after the end of ozone therapy).(At 24 weeks after the end of ozone therapy (approx. week 40).)
- Change from Baseline in Anxiety and Depression Levels (HAD Scale) (at the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
- Change from Baseline in Anxiety and Depression Levels (HAD Scale) (at 12 weeks after the end of ozone therapy).(At 12 week after the end of ozone therapy (approx. week 28).)
- Change from Baseline in Anxiety and Depression Levels (HAD Scale) (at 24 weeks after the end of ozone therapy).(At 24 week after the end of ozone therapy (approx. week 40).)
- Change from Baseline in Health-Related Quality of Life by the "QLQ-C30" Questionnaire (only in cancer patients). (At the end of ozone therapy).(At the end of ozone therapy (approx. week 16).)
研究者
Bernardino Clavo, MD, PhD
Principal Investigator, Research Unit Director
Dr. Negrin University Hospital