- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05211622
OZOCLO_MUCOSITIS: a New Protocol for Prevention of Oral Mucositis (OZOCLO_MUCOS)
OZOCLO: a Randomized Clinical Trial for Prevention of Oral Mucositis
Oral mucositis (OM) is a significant side effect of cytotoxic anti-cancer chemotherapy and HN radiotherapy. CT-associated OM (CT-OM). It is the ulcerative phase that is most painful and associated with poor health outcomes. The sequelae of CT-OM, which include pain, odyno/dys-phagia, dysgeusia, decreased oral intake and systemic infection, frequently require treatment delays, interruptions, and discontinuations that not only negatively impact the quality of life but also tumor control and survivorship. To date, OM management is aimed to control symptoms through topical or systemic analgesics and topical application of barrier agents to cover injured mucosa as a salve or ointment. According to the recent MASCC/ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy, no guideline was possible regarding the use of saline or sodium bicarbonate rinses in the prevention or treatment of OM-CT in patients undergoing cancer therapy because of limited data.
Ozone at low medical concentration, not included in MASCC guidelines, will be generally proven to induce a mild activation of protective anti-oxidant pathways, thus exerting therapeutic effects in many inflammatory diseases.
Aim: to evaluate the effectiveness of a new protocol OZOCLO (alpha-lipoic acid, ozonated oil, and chlorhexidine [CHX] mouthwash) compared to sodium bicarbonate solution (Oral Basic Care- OBC) or chlorhexidine (CHX) mouthwash alone or to a binomial administration (AAL-OZ) of systemic alpha-lipoic acid and topical ozonated oil to reduce the incidence of OM (primary aim) and/or to postpone the beginning of oral mucositis (OM) and to reduce OM severity (secondary aims).
Study Overview
Status
Detailed Description
Oral mucositis (OM) is a significant side effect of cytotoxic anti-cancer chemotherapy and HN radiotherapy. CT-associated OM (CT-OM) begins in the submucosa and becomes clinically on the surface about 4 days after infusion: typical primary manifestations are erythema, mucosal atrophy, and sensitivity. The process continues to deteriorate mucosae, and ulceration occurs a few days later, peaking at 2 weeks and persisting for 1-2 weeks after which it typically resolves spontaneously. It is the ulcerative phase that is most painful and associated with poor health outcomes. The sequelae of CT-OM, which include pain, odyno/dys-phagia, dysgeusia, decreased oral intake and systemic infection, frequently require treatment delays, interruptions, and discontinuations that not only negatively impact the quality of life but also tumor control and survivorship. To date, OM management is aimed to control symptoms through topical or systemic analgesics and topical application of barrier agents to cover injured mucosa as a salve or ointment. Although the investigators reviewed a large body of evidence, there are still, clinical settings for which there is no recommended intervention. According to the recent MASCC/ISOO Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy, no guideline was possible regarding the use of saline or sodium bicarbonate rinses in the prevention or treatment of OM-CT in patients undergoing cancer therapy because of limited data. Despite the limited data available for both saline and sodium bicarbonate, the panel recognizes that these are inert, bland rinses that increase oral clearance, which may help maintain oral hygiene and improve patient comfort. Also, CHX is indicated because of concurrent oral infection and OM, it is acceptable to use it for the oral infection.
Ozone at low medical concentration, not included in MASCC guidelines, will be generally proven to induce a mild activation of protective anti-oxidant pathways, thus exerting therapeutic effects in many inflammatory diseases.
Aim: to evaluate the effectiveness of a new protocol OZOCLO (alpha-lipoic acid, ozonated oil, and chlorhexidine [CHX] mouthwash) compared to sodium bicarbonate solution (Oral Basic Care- OBC) or chlorhexidine (CHX) mouthwash alone or to a binomial administration (AAL-OZ) of systemic alpha-lipoic acid and topical ozonated oil to reduce the incidence of OM (primary aim) and/or to postpone the beginning of oral mucositis (OM) and to reduce OM severity (secondary aims).
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Olga Di Fede, Professor
- Phone Number: +39 3294030298
- Email: olga.difede@unipa.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18-80 years
Planned to receive conventional chemotherapy such as:
- CMF (cyclophosphamide (Endoxan), methotrexate, 5-FU))
- Standard AC+T regimen (doxorubicin (Adriamycin)), cyclophosphamide (Endoxan), Taxane [paclitaxel (Taxol) or docetaxel (Taxotere)) or any combination of two or more components (e.g., ACT, TAC, TA, AT, AC)
- ABVD (doxorubicin (Adriamycin), bleomycin, vinblastine, dacarbazine)
- FOLFIRI (irinotecan, 5-FU, leucovorin)
- Any other 5-FU-based regimen
- Planned to receive at conventional new generation targeted agents (tyrosine-kinase inhibitors or monoclonal antibodies) such as cetuximab, axitinib, bevacizumab, sunitinib, and sorafenib, temsirolimus, everolimus, vemurafenib, dabrafenib.
- Be willing and able to complete all study-related activities
- Properly obtained written informed consent
Exclusion Criteria:
- Receiving any oxaliplatin-containing chemotherapy regimen, such as FOLFOX
- Concurrent radiotherapy
- Unable or unwilling to complete study assessments
- Concurrent participation in another interventional clinical study or use of another investigational agent within 30 days before randomization
- Any other clinical or psychiatric condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the protocol
- Chronic use of opioid analgesics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group I, OZOCLO
• Group I, OZOCLO
|
600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days
Other Names:
1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 2 weeks
Other Names:
1 minute- three times/die after oral hygiene, possibly, from five days after the beginning of chemotherapy and for subsequent 2 weeks
Other Names:
|
Placebo Comparator: Group II, OBC
• Group II, OBC Sodium bicarbonate 5% solution - mouthwash (1 minute- three times/die after oral hygiene, possibly) from the beginning of chemotherapy and for 3 weeks
|
1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 3 weeks
Other Names:
|
Active Comparator: Group III, CHX
• Group III, CHX Chlorhexidine 0,2% - mouthwash (1 minute- three times/die after oral hygiene, possibly) from five days after the beginning of chemotherapy and for subsequent 2 weeks
|
1 minute- three times/die after oral hygiene, possibly, from five days after the beginning of chemotherapy and for subsequent 2 weeks
Other Names:
|
Active Comparator: Group IV, AAL-OZ
• Group IV, AAL-OZ
|
600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days
Other Names:
1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 2 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of OM incidence
Time Frame: 7th, 14th, and the 21st day after application of the interventions
|
In order to demonstrate whether the new protocol OZOCLO determines change of the incidence of OM compared to sodium bicarbonate solution (OBC) or chlorhexidine (CHX) mouthwash alone or the binomial AAL-OZ combination, in patients treated with chemotherapy regimens.
|
7th, 14th, and the 21st day after application of the interventions
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delay onset of OM
Time Frame: 7th, 14th, and the 21st day after application of the interventions
|
In order to determine whether the new protocol OZOCLO determines a delay of onset for OM, considering that it currently begins at 7th day, compared to sodium bicarbonate solution (OBC) or chlorhexidine (CHX) mouthwash alone or a binomial administration of systemic alpha-lipoic acid and topical ozonated oil.
|
7th, 14th, and the 21st day after application of the interventions
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OM severity assessment
Time Frame: 7th, 14th, and the 21st day after application of the interventions
|
To reduce OM severity, assuming one-point score difference (assessed through the Oral Mucositis World Health Organization Toxicity Scale- from grade 0 - none to grade IV- Oral alimentation impossible) compared to chlorhexidine (CHX) mouthwash alone or a binomial administration of systemic alpha-lipoic acid and topical ozonated oil and two-point score difference compared to sodium bicarbonate solution at one year.
|
7th, 14th, and the 21st day after application of the interventions
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olga Di Fede, Professor, University of Palermo, Di.Chir.On.S
Publications and helpful links
General Publications
- Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28. Erratum In: Cancer. 2021 Oct 1;127(19):3700.
- Cardona A, Balouch A, Abdul MM, Sedghizadeh PP, Enciso R. Efficacy of chlorhexidine for the prevention and treatment of oral mucositis in cancer patients: a systematic review with meta-analyses. J Oral Pathol Med. 2017 Oct;46(9):680-688. doi: 10.1111/jop.12549. Epub 2017 Feb 8.
- Ferretti GA, Raybould TP, Brown AT, Macdonald JS, Greenwood M, Maruyama Y, Geil J, Lillich TT, Ash RC. Chlorhexidine prophylaxis for chemotherapy- and radiotherapy-induced stomatitis: a randomized double-blind trial. Oral Surg Oral Med Oral Pathol. 1990 Mar;69(3):331-8. doi: 10.1016/0030-4220(90)90295-4.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Stomatognathic Diseases
- Mouth Diseases
- Mucositis
- Stomatitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Protective Agents
- Dermatologic Agents
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin B Complex
- Disinfectants
- Pharmaceutical Solutions
- Chlorhexidine
- Thioctic Acid
- Chlorhexidine gluconate
Other Study ID Numbers
- OZOCLO_MUCOSITIS 01_2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mucositis (MeSH Unique ID: D052016)
-
Hacettepe UniversityCompletedCrowns (MeSH Unique ID: D003442), Single Tooth | Dental Porcelain (MeSH Unique ID: D003776)
-
Kıvanç AkçaHacettepe UniversityCompletedCementation (MeSH Unique ID: D002484) | Dental Implant-Abutment Design (MeSH Unique ID: D059605) | Crown (MeSH Unique ID: D003442) Surfaces | Contour: Crown (MeSH Unique ID: D003442) - Dental Implant (MeSH Unique ID: D015921) AbutmentTurkey
-
Baylor College of MedicineUniversity of Houston; Harris County Juvenile Probation Department; Connecticut... and other collaboratorsRecruitingSpecific Learning Disorder (MeSH Unique ID: D000067559) | Dyslexia (MeSH Unique ID: D004410) | Conduct Disorder (MeSH Unique ID: D019955)United States
-
National Institute of Neurological Disorders and...RecruitingNervous System Diseases (C10 Unique ID D009422)United States
-
Hasan Kalyoncu UniversityCompletedMuscle Strength | Postural Balance | Range of Motion, Articular | Walking Speed, Mesh id D000072797Turkey
Clinical Trials on 1. alpha acid lipoic - tables
-
InVasc Therapeutics, Inc.CompletedHypertension | DiabetesUnited States
-
Khyber Medical University PeshawarActive, not recruitingPeripheral Diabetic NeuropathyPakistan
-
Rebecca SpainCompletedComparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple SclerosisProgressive Multiple Sclerosis | Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Heba Allah Ali Abd El-Halim MabroukTanta UniversityUnknown
-
Seoul St. Mary's HospitalGlaxoSmithKlineTerminatedNASH (Non-alcoholic Steato-hepatitis)
-
Augusta UniversityXinjiang Medical UniversityCompletedObesity | Cardiovascular Disease | Type 2 DiabetesChina
-
Oregon State UniversityOregon Health and Science University; National Center for Complementary and...Active, not recruiting
-
University Health Network, TorontoCanadian Diabetes AssociationCompletedType 2 Diabetes | PrediabetesCanada
-
University of British ColumbiaRecruitingObstructive Sleep Apnea of AdultCanada