Effectiveness and cost-effectiveness of Ozone therapy in patients with pain secondary to peripheral neuropathy induced by chemotherapy. Randomized, placebo-controlled, clinical trial

2024-518021-16-00 Protocol O3NPIQ Phase II and Phase III (Integrated) Ongoing, recruiting

Start 30 Nov 2020 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol O3NPIQ

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)
Status Ongoing, recruiting
Participants planned 42
Countries 1
Sites 1

Pain secondary to chemotherapy-induced peripheral neuropathy

To assess the clinical effect and impact on self-perceived health related quality of life (HRQOL) by addition of Ozone therapy to the standard management of patients with cancer and suffering painful chemotherapy-induced peripheral neuropathy Grade > = 2 for > 3 months. To estimate the additional cost and the ratio of …

Key facts

Sponsor
Dr. Bernardino Clavo Varas
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10]
Trial duration
30 Nov 2020 → ongoing
Decision date (initial)
2024-09-26
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Instituto de Salud Carlos III

External identifiers

EU CT number
2024-518021-16-00
EudraCT number
2019-000821-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess the clinical effect and impact on self-perceived health related quality of life (HRQOL) by addition of Ozone therapy to the
standard management of patients with cancer and suffering painful chemotherapy-induced peripheral neuropathy Grade > = 2 for > 3
months. To estimate the additional cost and the ratio of cost-effectiveness of adding Ozone therapy to the regular treatment.

Secondary objectives 9

  1. 1. To evaluate changes in Quality of Life (QOL) according to the "EQ- 5D-5L" questionnaire
  2. 2. To evaluate changes in Quality of Life (QOL) according to the "SF- 36v2, 1 week" questionnaire.
  3. 3. To evaluate changes in biochemical parameters of oxidative stress.
  4. 4. To evaluate changes in biochemical parameters of inflammation.
  5. 5. To assess the diagnostic and predictive value of hiperespectral imaging in these patients.
  6. 6. To evaluate changes in the level of anxiety and depression according to the Hamilton scale.
  7. 7. To evaluate changes in nerve conduction studies in the painful area.
  8. 8. To evaluate the toxicity of rectal ozone therapy in these patients.
  9. 9. To evaluate the acceptability of a shared decision making (SDM) tool among professionals and patients

Conditions and MedDRA coding

Pain secondary to chemotherapy-induced peripheral neuropathy

VersionLevelCodeTermSystem organ class
20.1 LLT 10079545 Chemotherapy induced peripheral neuropathy 10029205

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. 1. Adults > = 18 years old.
  2. 2. Cancer in any stage, treated with chemotherapy, and life expectancy > 6 months.
  3. 3. Clinical diagnosis painful chemotherapy-induced peripheral neuropathy, toxicity Grade > 2 according to the Common Toxicity Criteria for Adverse Events (CTCAE) del National Cancer Institute de EEUU, v.5.0, for > 3 months and without the inclusion of new treatments for pain and/or neuropathy for > 1 month.
  4. 4. "Average pain" > 3/10 according to the Brief Pain Inventory-Short Form (BPI-SF) for > 3 months.
  5. 5. Pregnant women can not participate in the clinical trial.
  6. 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. 7. Patients who have signed and dated the study ʼs specific informed consent.

Exclusion criteria 15

  1. 1. Age < 18 years old.
  2. 2. Pregnancy at the time of enrollment.
  3. 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. 4. Clinical suspicion that peripheral neuropathy is due to compressive or diabetic neuropathy in the same area prior to receiving neurotoxic chemotherapy.
  5. 5. Psychiatric illness or social situations that would limit compliance with study requirements.
  6. 6. Those who are uncapable to fill in the scales used to measure quality of life variables
  7. 7. Specific liver enzymes [Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) > 5 times the upper limit of normal
  8. 8. Increased creatinine > 3 times the upper limit of normal.
  9. 9. Hemodynamically or clinically unstable patients or uncontrolled severe illness.
  10. 10. Neoplasia in progression
  11. 11. Leptomeningeal carcinomatosis.
  12. 12. Life expectancy < 6 months
  13. 13. Contraindication or disability for rectal ozone administration or to attend scheduled treatments.
  14. 14. Known allergy to ozone.
  15. 15. Patients who do not meet all the inclusion criteria.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. the “average pain” level according to the Brief Pain Inventory-Short Form (BPI-SF).
  2. Direct hospital costs. The use of hospital resources (medication, tests, medical visits, medical supplies, etc.) and the associated cost will be collected (from the information generated in the Admission, Accounting Management and Analytical Accounting Services of our Hospital).

Secondary endpoints 9

  1. 1. Quality of Life (QOL) measured by "EQ-5D-5L" questionnaire
  2. 2. Quality of Life (QOL) measured by "SF-36v2, 1 week" questionnaire.
  3. 3. Biochemical parameters of oxidative stresss
  4. 4. Biochemical parameters of inflammation
  5. 5. Hyperspectral image of painful area
  6. 6. Levels of anxiety and depression according to the Hamilton scale
  7. 7. Nerve conduction studies in the painful area
  8. 8. Toxicity of rectal ozone therapy in these patients.
  9. 9. Acceptability of a shared decision making (SDM) tool among professionals and patients

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Oxígeno Medicinal Gas Carburos Metálicos, 99.5% v/v gas comprimido medicinal

PRD321402 · Product

Active substance
Oxygen
Pharmaceutical form
MEDICINAL GAS, COMPRESSED
Route of administration
RECTAL USE
Max daily dose
9000 µg microgram(s)
Max total dose
9000 µg microgram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
V03AN01 — -
Marketing authorisation
66969
MA holder
S.E. CARBUROS METÁLICOS, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
El Ozono se obtiene a partir del Oxígeno, empleando un generador de Ozono autorizado (con marcado CE). En realidad, lo que obtenemos y administramos consiste en una mezcla de gas con “ > 95% O2 y < 5% O3 ” que no puede ser encapsulada ni almacenada, y debe ser producida y administrada in situ debido a su corta vida media.

Placebo 1

The Placebo is the diatomic allotrope of oxygen (O2) (Oxígeno Medicinal Gas Carburos Metálicos, 99'5%)

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dr. Bernardino Clavo Varas

Sponsor organisation
Dr. Bernardino Clavo Varas
Address
Barranco de la ballena s/n
City
Las Palmas de Gran Canaria
Country
Spain

Scientific contact point

Organisation
Dr. Bernardino Clavo Varas
Contact name
Dr. Bernardino Clavo Varas

Public contact point

Organisation
Dr. Bernardino Clavo Varas
Contact name
Dr. Bernardino Clavo Varas

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ongoing, recruiting 42 1
Rest of world — 0 —

Investigational sites

Spain

1 site · Ongoing, recruiting
El Hospital Universitario De Gran Canaria Dr. Negrin
Oncología Radioterápica, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2020-11-30 2020-11-30

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol O3NPIQ v02 20220831 2.0
Recruitment arrangements (for publication) K_recruitments arrangements in cover letter 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults O3NPIQ 2.0
Summary of Product Characteristics (SmPC) (for publication) G2_IMPD-1 SmPC Ficha tecnica del Oxigeno 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-20 Spain Acceptable with conditions
2024-09-26
 2024-09-26

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