Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis. (NCT05161091) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis.
France54 participantsStarted 2022-11-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Demonstrate the effectiveness of the curative treatment with Orosol® on mucositis score (WHO)
Timeframe: At day 28
2
Demonstrate the effectiveness of the curative treatment with Orosol® on mucositis score (NCI-CTCAE v3.0)
Timeframe: At day 28
3
Demonstrate the effectiveness of the curative treatment with Orosol® on oral feeding (NCI-CTCAE v4.0)