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Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis.

NCT05161091 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-08-12

No results posted yet for this study

Summary

Oral mucositis is one of the most debilitating side effects of radiation therapy and various forms of chemotherapy, especially for head and neck cancers and hematopoietic stem cell transplants.

It is a consequence of the cytostatic effects of anticancer treatments on rapidly renewing cells of the oral mucosa; An ulcer appears which will increase in size due to subsequent bacterial, fungal and / or viral growth, while the leakage of toxins through damaged capillaries causes irritation and a burning sensation. Proteolytic enzymes, known to destroy the extracellular matrix, inhibit cell regeneration and healing.

Depending on the severity of the ulceration, infection and feeding possibilities, mucositis is scored between grade 0 (absent) and grade 4 (maximum) (according to the WHO (World Health Organization) classification or the NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events), the latter degree most often requiring a modification of the anticancer treatment which may have an impact on the prognosis of the disease.

Although, theoretically, mucositis is easy to treat because it only requires simple cleaning of the ulcers and stimulation of the growth of the underlying healthy cells to make up for the loss of substance, there are currently only limited symptomatic treatments available.

Conditions

  • Oral Mucositis

Interventions

DEVICE

Topical application of Orosol®

Orosol® is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Orosol® every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product.

DEVICE

Topical application of Placebo comparator

Placebo comparator is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Placebo comparator every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product.

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Laurent Devoize · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • France

Study Locations

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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 NCT05161091 on ClinicalTrials.gov