OZOCLO_MUCOSITIS: a New Protocol for Prevention of Oral Mucositis
Status:
Not yet recruiting
Trial end date:
2023-01-10
Target enrollment:
Participant gender:
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).