OXYGEN for Chemotherapy-induced peripheral neuropathy | Paresthesia (numbness and tingling)

Inclusion criteria

• {"criterion_text":"- Adults > = 18 years old.\n- Previous treatment with any chemotherapy because of any tumor.\n- 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.\n- Without neurotoxic chemotherapy > = 3 months.\n- Cancer disease stable or in remission.\n- Life expectancy > = 6 months.\n- 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.\n- To sign and date the study specific informed consent"}

Exclusion criteria

• {"criterion_text":"- Age < 18 years.\n- Known allergy to ozone, known glucose 6 phosphate dehydrogenase (G6PD) deficiency, or hemochromatosis.\n- Contraindications or impossibility for rectal ozone treatment or to attend regularly to the treatment.\n- Not meeting each and every one of the inclusion criteria.\n- A woman who is lactating, pregnant, suspected of being pregnant, or who is of childbearing age and does not use adequate contraceptive methods.\n- Suspected symptoms are due to diabetic or compressive neuropathy.\n- Severe psychiatric disorders.\n- Inability to complete the quality of life questionnaires.\n- Elevation above 5 times the maximum limit of normal creatinine.\n- Patient who is hemodynamic or clinically unstable, or who requires urgent or short-term interventional measures.\n- Neoplasia in progression requiring recent initiation of systemic treatment, or maintenance with neurotoxic chemotherapy.\n- Life expectancy (for any reason) < 6 months."}

Primary endpoints

• {"endpoint_text":"- Change from Baseline in “paresthesia” (numbness, tingling) self perceived by patients (at the end of follow-up). Self-reported evaluation of the percentage in “Numbness\" and/or “Tingling” regarding the basal level. From 100% (basal level, 0% improvement) to 0% (no numbness or tingling, 100% improvement). [Time Frame: 28 weeks]","definition_or_measurement_approach":"Self-reported evaluation of the percentage in “Numbness\" and/or “Tingling” regarding the basal level, scale from 100% (baseline, 0% improvement) to 0% (no numbness/tingling, 100% improvement). Time frame: 28 weeks (measured at week 28)."}
• {"endpoint_text":"- Change from Baseline in quality of life by the EQ-5D-5L questionnaire (from EuroQol), (at the end of follow-up) 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) [Time Frame: 28 weeks]","definition_or_measurement_approach":"EQ-5D-5L questionnaire: five items scored 1-5 and a Visual Analogue Scale (0-100). Assessed at end of follow-up (week 28)."}

Secondary endpoints

• {"endpoint_text":"- Direct Hospital Cost The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 28 weeks of the study (in euros). [Time Frame: 28 weeks].","definition_or_measurement_approach":"Direct hospital expenses incurred during 28 weeks (medication, tests, visits), measured in euros at week 28."}
• {"endpoint_text":"- Change from Baseline in “paresthesia” (numbness, tingling) self-perceived by patients (at the end of ozone treatment). Self-reported evaluation of the percentage in “Numbness\" and/or “Tingling” regarding the basal level. From 100% (basal level, 0% improvement) to 0% (no numbness or tingling, 100% improvement). [Time Frame: 16 weeks]","definition_or_measurement_approach":"Self-reported percentage change in numbness/tingling relative to baseline, scale 100% to 0%; measured at end of ozone treatment (week 16)."}
• {"endpoint_text":"- Changes from Baseline in the grade of toxicity of paresthesias (numbness, tingling) according to the CTCAE v.5.0 scale (from the National Cancer Institute of EEUU). (at the end of ozone treatment). Range from: Grade 0 (asymptomatic or mild symptoms) to Grade 3 (severe symptoms, limiting self-care activities daily life) [Time Frame: 16 weeks]","definition_or_measurement_approach":"CTCAE v5.0 grading of paresthesia toxicity from Grade 0 to Grade 3; measured at end of ozone treatment (week 16)."}
• {"endpoint_text":"- Changes from Baseline in the grade of toxicity of sensory neuropathy according to the CTCAE v.5.0 scale (from the National Cancer Institute of EEUU). (at the end of ozone treatment). Range from: Grade 0 (asymptomatic or mild symptoms) to Grade 4 (life-threatening consequences; urgent intervention indicated) [Time Frame: 16 weeks]","definition_or_measurement_approach":"CTCAE v5.0 grading of sensory neuropathy from Grade 0 to Grade 4; measured at end of ozone treatment (week 16)."}
• {"endpoint_text":"- Changes from Baseline in the degree of neuropathy according to the QLQ-CIPN20 scale (from the European Organization for Research & Treatment in Cancer (EORTC)). (at the end of ozone treatment). It is evaluated through 20 items that are grouped into 3 dimensions: sensitive, motor and autonomic. Range: each item is scored from 1 (nothing) to 4 (a lot). The total score for each dimension is transformed into a scale from 0 to 100, being 0 the best state and 100 the worst. [Time Frame: 16 weeks]","definition_or_measurement_approach":"QLQ-CIPN20 (20 items grouped into 3 dimensions); items scored 1-4 and transformed to 0-100 per dimension; measured at week 16."}
• {"endpoint_text":"- Change from Baseline in quality of life by the EQ-5D-5L questionnaire (from EuroQol), (at the end of ozone treatment) 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) [Time Frame: 16 weeks]","definition_or_measurement_approach":"EQ-5D-5L assessment at end of ozone treatment (week 16), including 5 items (1-5) and VAS 0-100."}
• {"endpoint_text":"- Change from Baseline in quality of life by the QLQ-C30 questionnaire (EORTC), (at the end of ozone treatment) Self-reported evaluation of 30 items that measure several scales and symptoms. Range (after standardization): from 0 (worst for overall health and function, best for symptoms) to 100 (best for overall health and function, worst for symptoms). Time Frame: 16 weeks]","definition_or_measurement_approach":"QLQ-C30 assessed at week 16; standardized scores 0-100 for various scales/symptoms."}
• {"endpoint_text":"- Change from Baseline in Levels of anxiety and depression according to the “HAD scale” (at the end of ozone treatment) HAD scale is a self-administered questionnaire which assesses 14 items/symptoms of anxiety (7) and depression (7) experienced by patients. Each item is scored from 0 (better, no alteration) to 3 (worse level of alteration). For each symptom, overall score is from 0 (better, no anxiety or depression) to 21 (worse, very severe anxiety or depression). [Time Frame: 16 weeks]","definition_or_measurement_approach":"HAD scale (14 items) with subscales for anxiety and depression scored 0-21; measured at week 16."}
• {"endpoint_text":"- Changes from Baseline in biochemical parameters of oxidative stress (at the end of ozone treatment). Serum levels of biochemical parameters of oxidative stress. (at the end of ozone treatment). [Time Frame: 16 weeks]","definition_or_measurement_approach":"Serum biochemical markers of oxidative stress measured at end of ozone treatment (week 16)."}
• {"endpoint_text":"- Changes from Baseline in biochemical parameters of inflammation (if systemic ozone therapy) (at the end of ozone treatment). Serum levels of pro-inflammatory cytokines [Time Frame: 16 weeks]","definition_or_measurement_approach":"Serum pro-inflammatory cytokines measured at week 16 (if systemic ozone therapy)."}
• {"endpoint_text":"- Change from Baseline in Hyperspectral Image (HSI) of hands and feet (at the end of ozone treatment) Assessment of the percentage of reflectance for each wavelength [Time Frame: 16 weeks]","definition_or_measurement_approach":"Hyperspectral imaging reflectance percentage per wavelength for hands and feet measured at week 16."}
• {"endpoint_text":"- Change from Baseline in the grade of toxicity of paresthesias (numbness, tingling) according to the CTCAE v.5.0 scale (from the National Cancer Institute of EEUU). (at the end of follow-up). Range from: Grade 0 (asymptomatic or mild symptoms) to Grade 3 (severe symptoms, limiting self-care activities daily life) [Time Frame: 28 weeks]","definition_or_measurement_approach":"CTCAE v5.0 grading of paresthesia toxicity assessed at end of follow-up (week 28)."}
• {"endpoint_text":"- Changes from Baseline in the grade of toxicity of sensory neuropathy according to the CTCAE v.5.0 scale (from the National Cancer Institute of EEUU). (at the end of follow-up). Range from: Grade 0 (asymptomatic or mild symptoms) to Grade 4 (life-threatening consequences; urgent intervention indicated) [Time Frame: 28 weeks]","definition_or_measurement_approach":"CTCAE v5.0 grading of sensory neuropathy assessed at week 28."}
• {"endpoint_text":"- Changes from Baseline in the degree of neuropathy according to the QLQ-CIPN20 scale (from the European Organization for Research & Treatment in Cancer (EORTC)). (at the end of follow-up). It is evaluated through 20 items that are grouped into 3 dimensions: sensitive, motor and autonomic. Range: each item is scored from 1 (nothing) to 4 (a lot). The total score for each dimension is transformed into a scale from 0 to 100, being 0 the best state and 100 the worst. [Time Frame: 28 weeks]","definition_or_measurement_approach":"QLQ-CIPN20 assessed at week 28; items 1-4 transformed to 0-100 by dimension."}
• {"endpoint_text":"- Change from Baseline in quality of life by the QLQ-C30 questionnaire (EORTC), (at the end of follow-up) Self-reported evaluation of 30 items that measure several scales and symptoms. Range (after standardization): from 0 (worst for overall health and function, best for symptoms) to 100 (best for overall health and function, worst for symptoms). Time Frame: 28 weeks]","definition_or_measurement_approach":"QLQ-C30 standardized scores measured at week 28."}
• {"endpoint_text":"- Change from Baseline in Levels of anxiety and depression according to the “HAD scale” (at the end of follow-up) HAD scale is a self-administered questionnaire which assesses 14 items/symptoms of anxiety (7) and depression (7) experienced by patients. Each item is scored from 0 (better, no alteration) to 3 (worse level of alteration). For each symptom, overall score is from 0 (better, no anxiety or depression) to 21 (worse, very severe anxiety or depression). [Time Frame: 28 weeks]","definition_or_measurement_approach":"HAD scale assessed at week 28 (anxiety and depression subscales scored 0-21)."}
• {"endpoint_text":"- Changes from Baseline in biochemical parameters of oxidative stress (at the end of ozone treatment). Serum levels of biochemical parameters of oxidative stress. (at the end of follow-up). [Time Frame: 28 weeks]","definition_or_measurement_approach":"Serum oxidative stress biochemical markers measured at week 28."}
• {"endpoint_text":"- Changes from Baseline in biochemical parameters of inflammation (if systemic ozone therapy) (at the end of follow-up). Serum levels of pro-inflammatory cytokines [Time Frame: 28 weeks]","definition_or_measurement_approach":"Serum pro-inflammatory cytokines measured at week 28 (if systemic ozone therapy)."}
• {"endpoint_text":"- Change from Baseline in Hyperspectral Image (HIS) of hands and feet (at the end of follow-up) Assessment of the percentage of reflectance for each wavelength [Time Frame: 28 weeks]","definition_or_measurement_approach":"Hyperspectral imaging reflectance percentage per wavelength measured at week 28."}
• {"endpoint_text":"- Toxicity of rectal ozone therapy in these patients. at the end of follow-up. [Time Frame: 28 weeks]","definition_or_measurement_approach":"Assessment of toxicity related to rectal ozone therapy at week 28."}

Spain

Earliest CTIS Part Ii Submission Date

26-10-2024

Latest Decision Or Authorization Date

20-11-2024

Processing Time Days

25

Number Of Sites

1

Number Of Participants

42

Primary sponsor

Full Name

El Hospital Universitario De Gran Canaria Dr. Negrin

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Instituto de Salud Carlos III (ISCIII), Spanish Ministry of Science and Innovation (and ERDF)","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"Spain","full_name":"Cabildo de Gran Canaria, Las Palmas, Spain","duties_or_roles":"Monetary support","organisation_type":""}