Efficacy of Orosol® in the Treatment of Chemo- and Radiation-induced Mucositis.
ConditionOral Mucositis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Topical application of Orosol®
DeviceOrosol® is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Orosol® every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product.
Topical application of Placebo comparator
DevicePlacebo comparator is a 20 ml aluminum bottle equipped with a spray without propellant gas for local application. Simply shake the bottle gently, apply the product to the injured surface by pressing your finger on the spray to deliver the product (4 to 5 times so as to form a thin film on the surface of the mouth) . It is recommended to use Placebo comparator every 2 hours at the start of treatment and then 3 to 4 times a day. The maximum duration of treatment will be 28 days. Eating or drinking should be avoided for the first 15 to 30 minutes after applying the product.
Treatment groups
54 Participants
are divided into 4 treatment groupsGroup A: Radio-induced oral mucositis / Medical DeviceExperimental treatment 1 intervention
Group B: Radio-induced oral mucositis / Placebo comparatorPlacebo comparator 1 intervention
Group C: Chemo-induced oral mucositis / Medical DeviceExperimental treatment 1 intervention
Group D: Chemo-induced oral mucositis / placebo comparatorPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Demonstrate the effectiveness of the curative treatment with Orosol® on mucositis score (WHO)
Evolution the symptoms of chemo-induced or radiation-induced mucositis by collecting the mucositis score according to the World Health Organization scale (from 0 (absence of mucositis) to 4 (Oral feeding not possible, enteral (tube) or parenteral feeding indicated))
Time frame
At day 282
Demonstrate the effectiveness of the curative treatment with Orosol® on mucositis score (NCI-CTCAE v3.0)
Evolution the symptoms of chemo-induced or radiation-induced mucositis by collecting the mucositis score according to the National Cancer Institute Common Terminology Criteria for Adverse Events (clinical scale) (v 3.0) (from 0 (absence of mucositis) to 4 (Necrosis, spontaneous hemorrhage))
Time frame
At day 283
Demonstrate the effectiveness of the curative treatment with Orosol® on oral feeding (NCI-CTCAE v4.0)
Evolution the symptoms of chemo-induced or radiation-induced mucositis by collecting the difficulty in feeding orally with the functional signs scale from the National Cancer Institute Common Terminology Criteria for Adverse Events (functional scale) (v 4.0) (from 0 (absence of mucositis) to 4 (Necrosis, Vital prognosis engaged))
Time frame
At day 28Secondary outcomes
1
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item voice"
The OAG "item voice" scale is a scale from 1 (Normal) to 3 (highly impacted) assessing the difficulty of speaking
Time frame
At day 1, 3 , 5, 7, 14, 21 and 282
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item swallowing"
The OAG "item swallowing" scale is a scale from 1 (Normal) to 3 (highly impacted) assessing the difficulty of swallowing
Time frame
At day 1, 3 , 5, 7, 14, 21 and 283
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item tongue aspect"
The OAG "item tongue aspect" scale is a scale from 1 (pink, wet and presence of taste buds) to 3 (cracked, blistered) assessing the aspect of the tongue
Time frame
At day 1, 3 , 5, 7, 14, 21 and 284
Assessment of general state of health of the mouth with Oral Assessment Guide (OAG) scale "item salivation"
The OAG "item salivation" scale is a scale from 1 (normal) to 3 (absence of salivation) assessing the hyposialia
Time frame
At day 1, 3 , 5, 7, 14, 21 and 28Sponsors and contacts
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Source ClinicalTrials.gov