Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

February 7, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

March 31, 2030

Conditions
Chemotherapy Induced Peripheral Neuropathy (CIPN)ParesthesiaNumbnessTingling
Interventions
DRUG

Ozone therapy

Usual treatment (by their oncologist or hematologist) + Ozone therapy by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.

DRUG

Oxygen (placebo)

Usual treatment (by their oncologist or hematologist) + Oxygen by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.

Trial Locations (1)

35019

RECRUITING

Dr. Negrín University Hospital, Las Palmas

All Listed Sponsors
collaborator

Council of Gran Canaria

OTHER

collaborator

CIBER (Infectious diseases)

UNKNOWN

collaborator

Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias

OTHER

collaborator

Complejo Hospitalario Universitario Insular Materno Infantil

OTHER

collaborator

Servicio de Evaluacion del Servicio Canario de Salud.

UNKNOWN

collaborator

Institute for Applied Microelectronics, University of Las Palmas de Gran Canaria, Spain

UNKNOWN

collaborator

Instituto de Salud Carlos III

OTHER_GOV

lead

Bernardino Clavo, MD, PhD

OTHER