A phase II, multicentre, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of Clonidine Lauriad® 50 µg and 100 µg mucoadhesive buccal tablet (MBT) applied once daily in patients to those of placebo in the prevention and treatment of chemoradion therapy-induced oral mucositis in patients with head and neck cancer

Conditions: Prevention and treatment of chemoradion therapy-induced oral mucositis.

Registration Number: EUCTR2009-014870-16-FR

Lead Sponsor: BioAlliance Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 183

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

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 (< 60 b/min), including sinus node dysfunction or AV nodal conduction block 2nd or 3rd degree.
11.Severe renal insufficiency (creatinine blood level > 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