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OZOCLO_MUCOSITIS: a New Protocol for Prevention of Oral Mucositis

NCT05211622 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-01-27

No results posted yet for this study

Summary

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).

Conditions

  • Mucositis (MeSH Unique ID: D052016)
  • Stomatitis (MeSH Unique ID: D013280)

Interventions

DRUG

1. alpha acid lipoic - tables

600 mg/die per os from 7 days before the beginning of chemotherapy and continue for other 4 days

DRUG

2. ozonated oil - mouthwash

1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 2 weeks

DRUG

3. 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

DRUG

4. sodium bicarbonate 5% solution - mouthwash

1 minute- three times/die after oral hygiene, possibly, from the beginning of chemotherapy and for 3 weeks

Sponsors & Collaborators

  • University of Palermo

    lead OTHER

Principal Investigators

  • Olga Di Fede, Professor · University of Palermo, Di.Chir.On.S

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2022-12-31
Completion
2023-01-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05211622 on ClinicalTrials.gov