Prevention and treatment of chemoradion therapy-induced oral mucositis.
Conditions
Interventions
Product Name: Clonidine Lauriad
Product Code: BA028
Pharmaceutical Form: Muco-adhesive buccal tablet
INN or Proposed INN: CLONIDINE
CAS Number: 4205907
Current Sponsor code: BA028
Other descriptive na
Sponsors
BioAlliance Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. Aged >18 years 3. Suffering from a newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx histologically-confirmed and having undergone resective surgery 4. eligible to receive: a. a continuous course of conventional external beam irradiation (IRMT eligible) with a minimum cumulative radiation dose of 50 Gy and a maximum of 70 Gy, based on a daily dosing between 1.8 and 2.2 Gy. Planned radiation treatment fields must include at least two oral tissue sites (among buccal mucosa, floor of the mouth, tongue, soft palate) with each site receiving a total of 50 Gy or a maximum of 70 Gy. b. Chemotherapy consisting of standard dosing of cisplatin or carboplatin administered in standard weekly or tri-weekly cycles 5. Karnofsky performance scale > 60% or ECOG = 2 6. Screening laboratory tests a. Hemoglobin = 10g/dL b. White blood count = 3500 cells/mm3 c. Absolute neutrophil counts = 1500 cells/mm3 d. Direct bilirubin = 2 times Upper Limit of Normal (ULN) e. Serum AST and ALT = 3 ULN f. Serum creatinine = 2 mg/dL g. Serum or urine pregnancy test: Negative 8. Women of child bearing potential must have effective contraception method (oral or device) 7. Signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: 1. Head and neck tumours of the lips, sinuses, salivary glands, or unknown primary site 2. Prior radiation of the head and neck area 3. Prior chemotherapy 4. Curative surgery within less than 2 weeks or more than 10 weeks prior to the initiation of RT-CT 5. Presence of active infectious disease 6. Presence of active oral infectious disease, including oropharyngeal candidiasis and/or orofacial herpes 7. Presence of oral mucositis 8. Known or suspected chronic viral diseases including HIV 9. Recent stroke within the last 6 months 10. Bradyarrhythmia ( 1.5ULN) 12. Administration of any concomitant treatment likely to interfere with clonidine 13. Ongoing heavy alcohol consumption (>100g alcohol/day) 14. Known hypersensitivity to clonidine, history of allergy or intolerance to milk proteins or any other component of the product 15. Presence of severe or uncontrolled depression 16. Pregnant or breast-feeding women 17. Inability to give informed consent or comply with study requirements 18. Unable or unwilling to comply with follow-up visits 19. Participation to a clinical trial within 30 days prior to randomization and during the entire duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of Clonidine Lauriad® 50 µg and 100 µg mucoadhesive buccal tablet versus placebo in the prevention and treatment of chemoradiotherapy induced oral mucositis.;Secondary Objective: - To determine the optimal dose of clonidine Lauriad® mucoadhesive buccal tablet - To determine the plasma and salivary pharmacokinetic parameters of Clonidine Lauriad® 50 µg and 100 µg mucoadhesive buccal tablet - To evaluate the quality of life of cancer patients treated with Clonidine Lauriad® MBT during radiochemotherapy - To evaluate the duration of mucoadhesive buccal tabletadhesion. - To evaluate the local and overall safety of Clonidine Lauriad® mucoadhesive buccal tablet - To preliminary evaluate the health economics in patients undergoing chemoradiotherapy treated with Clonidine Lauriad® mucoadhesive buccal tabletand placebo ;Primary end point(s): comparison between groups of the: Percentage of patients with an oral mucositis score = 3 at cumulative radiation dose 50 Gy evaluated using the WHO scale | — |
Countries
France, Germany, Hungary, Spain
Outcome results
None listed