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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Oral Mucositis

In brief

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.

Key facts

Study ID

NCT05161091

Run by

University Hospital, Clermont-Ferrand

People needed

54

Starts

2022-11-22

Expected to finish

2026-12-01

Last updated by the study team

2024-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patient, male or female, either
• treated with chemotherapy for hematological cancer (leukemia, lymphoma) and suffering from grade 2 to 4 mucositis (according to WHO / NCI-CTCAE), or
• treated with radiotherapy or radio-chemotherapy (cisplatin or cetuximab) for head and neck cancer and suffering from grade 2 to 4 mucositis (according to WHO / NCI-CTCAE),
• Agreeing not to take any treatment for mucositis other than the treatment proposed in this study, apart from the classic symptomatic treatment for mucositis recommended by WHO.
• Able to give informed consent to participate in research.
• Beneficiary of a Social Security scheme.

You may not qualify if…

• A woman who is pregnant, breastfeeding, or may be.
• Major subject under guardianship, curators, deprived of liberty, or under the safeguard of justice.
• Medical and / or surgical history deemed by the investigator to be incompatible with the study because it would invalidate any reliable assessment.
• General state of health considered pejorative (Karnofsky index <60).
• Type 1 or type 2 diabetic subject (presence of honey in Orosol®).
• Subject on an anticoagulant (AVK or AOD) (interaction of the cranberry contained in Orosol® with anticoagulants (in particular warfarin) with instability of the International Normalized Ratio; the AODs can potentially present the same type of interaction).
• History of administration of the treatment (or equivalent) in the study.
• Anticipated difficulties in reading / understanding the protocol and its questionnaires.
• Subjects in the exclusion period from another clinical trial
• Refusal of participation.

Where it is running

• CHU clermont-ferrand — Clermont-Ferrand, France (enrolling)
• Centre Jean-Perrin — Clermont-Ferrand, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.