Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025

NCT05417737 | Recruiting

• 2 other identifiers: DrNegrinUH2022-203-1
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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 HUGCDN Chronic Pain Unit for adjuvant palliative treatment with ozone therapy between June-2022 and December-2025

Conditions

Radiation Toxicity; Chemotherapeutic Toxicity; Chemotherapy-induced Peripheral Neuropathy; Delayed Wound Healing; Chronic Pain; Refractory Pain

Keywords

Chemotherapy-induced Peripheral Neuropathy; Radiation-induced toxicity; Cancer-treatment side effects; Delayed wound healing; Chronic pain; Health-related quality of life; Anxiety and Depression; Ozone therapy; Refractory pain

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the health-related quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at the end of ozone therapy)

  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

Secondary Outcomes (23)

• Change from Baseline in Levels of anxiety and depression according to the hospital anxiety/depression scale (at the end of ozone therapy)

  16 weeks

• Change from Baseline in pain score according to the visual analog scale (VAS) (at the end of ozone therapy)

  16 weeks

• 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)

  16 weeks

• Changes from Baseline in requirements of invasive procedures (surgery, blood transfusions, and therapeutic endoscopic procedures) required for symptom management (at the end of ozone therapy)

  16 weeks

• Changes from Baseline in the main symptoms (at the end of ozone therapy)

  16 weeks

Study Arms (1)

Ozone group

Patients treated with ozone as adjuvant palliative therapy. The procedure of ozone administration, dosage, frequency, and duration of ozone treatment will depend on the treated symptom and clinical evolution. Usually planned 40 sessions.

Other: Ozone therapy

Interventions

Ozone therapy OTHER

Systemic and/or local ozone administration. Dosage, frequency, and duration of ozone treatment will depend on the treated symptom and clinical evolution. Usually planned 40 sessions.

Ozone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients submitted to the Chronic Pain Unit of the Hospital Universitario de Gran Canaria Dr. Negrín for symptomatic/palliative treatment with ozone therapy because standard treatment does not exist, it has been unsuccessful, or it is associated with high risk or high morbidity.

You may qualify if:

• Adults \> = 18 years old.
• Patients submitted to the Chronic Pain Unit of the Hospital Universitario de Gran Canaria Dr. Negrín for symptomatic/palliative treatment with ozone therapy because conventional treatment does not exist, it has been unsuccessful, or it is associated with high risk or high morbidity.
• After evaluation of symptoms and patients, it exists a potential benefit of adding ozone treatment to the current treatment.
• Patients have no contraindications for ozone treatment.
• Patients have signed and dated the informed consent for the compassionated ozone treatment and the specific informed consent for this study

You may not qualify if:

• Age \< 18 years old.
• Psychiatric illness or social situations that would limit compliance with study requirements.
• Those who are incapable to fill in the scales used to measure variables.
• Hemodynamically or clinically unstable patients or uncontrolled severe illness.
• Uncontrolled cancer disease requiring chemotherapy treatment.
• Life expectancy \< 6 months
• Contraindication or disability or to attend scheduled treatments.
• Known allergy to ozone.
• Pregnancy at the time of enrollment (for systemic ozone therapy). 10 Hemochromatosis (for systemic ozone therapy).
• \. Known significant glucose-6-phosphate dehydrogenase deficiency (favism, acute hemolytic anemia) (for systemic ozone therapy).

Sponsors & Collaborators

• Bernardino Clavo, MD, PhD: lead
• Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias: collaborator
• Servicio Canario de Salud: collaborator
• Council of Gran Canaria: collaborator
• Red de Investigación en Servicios de Salud en Enfermedades Crónicas: collaborator
• Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna: collaborator

Study Sites (1)

Dr. Negrín University Hospital

Las Palmas, Las Palmas, 35019, Spain

RECRUITING

Related Publications (11)

• Clavo B, Martinez-Sanchez G, Rodriguez-Esparragon F, Rodriguez-Abreu D, Galvan S, Aguiar-Bujanda D, Diaz-Garrido JA, Canas S, Torres-Mata LB, Fabelo H, Tellez T, Santana-Rodriguez N, Fernandez-Perez L, Marrero-Callico G. Modulation by Ozone Therapy of Oxidative Stress in Chemotherapy-Induced Peripheral Neuropathy: The Background for a Randomized Clinical Trial. Int J Mol Sci. 2021 Mar 10;22(6):2802. doi: 10.3390/ijms22062802.

  PMID: 33802143 BACKGROUND

• Clavo B, Navarro M, Federico M, Borrelli E, Jorge IJ, Ribeiro I, Rodriguez-Melcon JI, Carames MA, Santana-Rodriguez N, Rodriguez-Esparragon F. Long-Term Results with Adjuvant Ozone Therapy in the Management of Chronic Pelvic Pain Secondary to Cancer Treatment. Pain Med. 2021 Sep 8;22(9):2138-2141. doi: 10.1093/pm/pnaa459. No abstract available.

  PMID: 33738491 BACKGROUND

• Clavo B, Navarro M, Federico M, Borrelli E, Jorge IJ, Ribeiro I, Rodriguez-Melcon JI, Carames MA, Santana-Rodriguez N, Rodriguez-Esparragon F. Ozone Therapy in Refractory Pelvic Pain Syndromes Secondary to Cancer Treatment: A New Approach Warranting Exploration. J Palliat Med. 2021 Jan;24(1):97-102. doi: 10.1089/jpm.2019.0597. Epub 2020 May 5.

  PMID: 32379556 BACKGROUND

• Clavo B, Rodriguez-Esparragon F, Rodriguez-Abreu D, Martinez-Sanchez G, Llontop P, Aguiar-Bujanda D, Fernandez-Perez L, Santana-Rodriguez N. Modulation of Oxidative Stress by Ozone Therapy in the Prevention and Treatment of Chemotherapy-Induced Toxicity: Review and Prospects. Antioxidants (Basel). 2019 Nov 26;8(12):588. doi: 10.3390/antiox8120588.

  PMID: 31779159 BACKGROUND

• Clavo B, Santana-Rodriguez N, Llontop P, Gutierrez D, Suarez G, Lopez L, Rovira G, Martinez-Sanchez G, Gonzalez E, Jorge IJ, Perera C, Blanco J, Rodriguez-Esparragon F. Ozone Therapy as Adjuvant for Cancer Treatment: Is Further Research Warranted? Evid Based Complement Alternat Med. 2018 Sep 9;2018:7931849. doi: 10.1155/2018/7931849. eCollection 2018.

  PMID: 30271455 BACKGROUND

• Clavo B, Santana-Rodriguez N, Llontop P, Gutierrez D, Ceballos D, Mendez C, Rovira G, Suarez G, Rey-Baltar D, Garcia-Cabrera L, Martinez-Sanchez G, Fiuza D. Ozone Therapy in the Management of Persistent Radiation-Induced Rectal Bleeding in Prostate Cancer Patients. Evid Based Complement Alternat Med. 2015;2015:480369. doi: 10.1155/2015/480369. Epub 2015 Aug 18.

  PMID: 26357522 BACKGROUND

• Clavo B, Santana-Rodriguez N, Gutierrez D, Lopez JC, Suarez G, Lopez L, Robaina F, Bocci V. Long-term improvement in refractory headache following ozone therapy. J Altern Complement Med. 2013 May;19(5):453-8. doi: 10.1089/acm.2012.0273. Epub 2012 Dec 7.

  PMID: 23215625 BACKGROUND

• Clavo B, Ceballos D, Gutierrez D, Rovira G, Suarez G, Lopez L, Pinar B, Cabezon A, Morales V, Oliva E, Fiuza D, Santana-Rodriguez N. Long-term control of refractory hemorrhagic radiation proctitis with ozone therapy. J Pain Symptom Manage. 2013 Jul;46(1):106-12. doi: 10.1016/j.jpainsymman.2012.06.017. Epub 2012 Oct 26.

  PMID: 23102757 BACKGROUND

• Clavo B, Santana-Rodriguez N, Lopez-Silva SM, Dominguez E, Mori M, Gutierrez D, Hernandez MA, Robaina F. Persistent PORT-A-CATH(R)-related fistula and fibrosis in a breast cancer patient successfully treated with local ozone application. J Pain Symptom Manage. 2012 Feb;43(2):e3-6. doi: 10.1016/j.jpainsymman.2011.09.002. No abstract available.

  PMID: 22248793 BACKGROUND

• Clavo B, Suarez G, Aguilar Y, Gutierrez D, Ponce P, Cubero A, Robaina F, Carreras JL. Brain ischemia and hypometabolism treated by ozone therapy. Forsch Komplementmed. 2011;18(5):283-7. doi: 10.1159/000333795. Epub 2011 Oct 13.

  PMID: 22105041 BACKGROUND

• Clavo B, Gutierrez D, Martin D, Suarez G, Hernandez MA, Robaina F. Intravesical ozone therapy for progressive radiation-induced hematuria. J Altern Complement Med. 2005 Jun;11(3):539-41. doi: 10.1089/acm.2005.11.539.

  PMID: 15992242 BACKGROUND

MeSH Terms

Conditions

Radiation Injuries; Chronic Pain; Pain, Intractable; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Bernardino Clavo, MD, PhyD

  Dr. Negrín University Hospital, Las Palmas, Spain

  STUDY CHAIR

• Pedro G Serrano-Aguilar, MD, PhyD

  Servicio de Evaluación. Servicio Canario de Salud. Spain

  STUDY DIRECTOR

• Bernardino Clavo, MD, PhyD

  Dr. Negrín University Hospital, Las Palmas, Spain

  PRINCIPAL INVESTIGATOR

• Miguel A Caramés-Álvarez, MD

  Dr. Negrín University Hospital, Las Palmas, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernardino Clavo, MD, PhyD

CONTACT

(34)928449278; bernardinoclavo@gmail.com

Francisco Rodríguez-Esparragón, BSci, PhyD

CONTACT

(34)928449288; afrodesp@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Head of Research Unit

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 14, 2022
• Study Start: June 15, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)