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

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Dec 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Orosol® for patients who have oral mucositis, a painful condition that can occur after chemotherapy or radiation therapy, particularly in those being treated for head and neck cancers. Oral mucositis causes painful sores in the mouth, which can make eating and talking difficult. The trial aims to see if Orosol® can help reduce these sores and improve patients' comfort during treatment.

To participate in this study, individuals should be adults who are currently undergoing chemotherapy for blood cancers or radiation for head and neck cancers and have moderate to severe oral mucositis. Eligible participants will need to agree not to use other treatments for mucositis during the study, except for standard care recommended by health professionals. Those who join the trial can expect to receive the Orosol® treatment and will be monitored to assess its effectiveness and any side effects. It's important to note that certain individuals, such as pregnant women or those with specific health conditions, will not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.