Treatment of oral mucositis caused by chemotherapy and radiation
Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis. Randomized, Double-blind, Placebo-controlled Trial.
This study is testing if a new mouth solution called Orosol® can help people with painful mouth sores caused by chemotherapy and radiation feel better and heal faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | cetuximab, chemotherapy, radiation |
| Locations | 2 sites (Clermont-Ferrand and 1 other locations) |
| Trial ID | NCT05161091 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults undergoing chemotherapy for hematological cancers or radiation therapy for head and neck cancers, experiencing moderate to severe mucositis.
Not a fit: Patients who are pregnant, breastfeeding, or have medical histories incompatible with the study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve the quality of life for patients suffering from oral mucositis.
How similar studies have performed: Preliminary studies have shown improvement with Orosol® in treating chemo-induced mucositis, but its effectiveness for radiation-induced mucositis is yet to be tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Clermont-Ferrand and 1 other locations
- Centre Jean-Perrin — Clermont-Ferrand, France (Not_yet_recruiting)
- CHU clermont-ferrand — Clermont-Ferrand, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.