Treatment of oral mucositis caused by chemotherapy and radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of Orosol®, a viscous solution, in treating oral mucositis resulting from chemotherapy and radiation therapy. The study focuses on patients with grade 2 to 4 mucositis, assessing how Orosol® can alleviate symptoms by mechanically cleansing ulcers and promoting healing. Participants will receive either the active treatment or a placebo, with the aim of determining the therapeutic benefits of Orosol® compared to standard care. The trial is conducted at the University Hospital in Clermont-Ferrand, where patients will be monitored for improvements in their condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU clermont-ferrand
  Clermont-Ferrand, France Recruiting
• Centre Jean-Perrin
  Clermont-Ferrand, France Not yet recruiting

Study contacts

• Principal investigator: Laurent Devoize — University Hospital, Clermont-Ferrand
• Study coordinator: Lise Laclautre
• Email: promo_interne_drci@chu-clermontferrand.fr
• Phone: 334.73.754.963

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.