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Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis. Randomized, Double-blind, Placebo-controlled Trial.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Centre Jean-Perrin
NOT_YET_RECRUITING
Clermont-ferrand
CHU clermont-ferrand
RECRUITING
Clermont-ferrand
Contact Information
Primary
Lise Laclautre
promo_interne_drci@chu-clermontferrand.fr
334.73.754.963
Time Frame
Start Date: 2022-11-22
Estimated Completion Date: 2026-12
Participants
Target number of participants: 54
Treatments
Experimental: Radio-induced oral mucositis / Medical Device
Patient with radio-induced oral mucositis at least grade 2 treated with experimental medical device
Placebo_comparator: Radio-induced oral mucositis / Placebo comparator
Patient with radio-induced oral mucositis at least grade 2 treated with placebo
Experimental: Chemo-induced oral mucositis / Medical Device
Patient with chemo-induced oral mucositis at least grade 2 treated with experimental medical device
Placebo_comparator: Chemo-induced oral mucositis / placebo comparator
Patient with chemo-induced oral mucositis at least grade 2 treated with placebo
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov

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