Children affected or at risk of oral mucositis from chemoterapy and/or radiotherapy MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Samital
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: VACCINIUM MYRTILLUS ESTRATTO SECCO
CAS Number: 8001000-49-5
Current Sponsor code: non applicabile
Other des
Sponsors
AZIENDA OSPEDALIERA DI PADOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient is 2 to 17 years and 364 days • Karnofsky / Lansky Performance Status = 70 • Predicted life expectancy of = 6 months • Ability to take the study medication as prescribed • Willingness to undergo follow-up checks • Use of adequate contraception if patient is female of reproductive potential • Written Informed Consent. GROUP A - therapy: • Patients suffering from mucositis CT / RT-induced, = grade 2 (WHO) whatever treatment plan CT / RT they will receive. GROUP B - prophylaxis: Patients at risk of developing mucositis for the following reasons: a) diagnosis of acute lymphocytic leukemia, non-Hodgkin lymphoma, Ewing's sarcoma, Soft tissue sarcomas or other cancers for which is scheduled Metothrexate treatment with high doses, anthracyclines and / or Alkylating. b) Patients will receive high-dose therapy with autologous stem cell transplantation. c) Patients will receive radiotherapy to head and neck. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · Previous irradiation of the oral mucosa and / or oropharynx, larynx, hypopharynx · Contraindications to the administration of full doses of CT · Chronic use of steroids or immunosuppressive drugs · Pregnancy. · Inability by the patient (or parents / legal guardians), based on PI's opinion, to adhere to the requirements of the protocol · Presence of other medical conditions besides oncological therapies potentially causing mucositis (eg. reflux, rheumatologic diseases).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the feasibility of administering SAMITAL¿ in different ages in pediatric patients with oncological diseases at risk of developing or with oral mucositis induced by CT and / or RT;Secondary Objective: Evaluate the efficacy of SAMITAL¿ in addition to standard treatment in the prevention and treatment of mucositis CT / RT-induced. Determine the pharmacokinetics of SAMITAL¿ to determine whether systemic absorption of the main active ingredients. Assess the palatability of SAMITAL¿ in different age groups;Primary end point(s): The primary endpoint of this study is the feasibility of SAMITAL® administration, defined as the ability of children, especially younger ones, to assume the product with intact or damaged oral mucosa. The primary endpoint includes: · Evaluation of the compliance of the enrolled patients · Evaluation of DLT for each dose-escalation.;Timepoint(s) of evaluation of this end point: At each scheduled visit as per flow-chart | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assesment of mucositis severity and of pain; Determination of plasma concentration curves of the active ingredients of Samital; Evaluation of palatability of IP assessed with Likert with age-appropriate visual-analogical scale;Timepoint(s) of evaluation of this end point: At each scheduled visit; Predose, after 30 minutes, 24 hours, 96 hours, 168 hours; The day before start of tretment and after 7 and 14 days | — |
Countries
Italy
Contacts
Public ContactUOC Oncoematologia Pediatrica
Azienda Ospedaliera di Padova
Outcome results
None listed