Clinical study to evaluate the safety and efficacy of a mucoadhesive buccal tablet to treat mucositis (inflammation of the oral mucosa) due toradiotherapy and chemotherapy in patients treated for a head and neck cancer

• Conditions: Prevention and treatment of oral mucositis in head and neck cancer patients undergoing chemo-radiation therapy; MedDRA version: 17.0Level: PTClassification code 10037763Term: Radiation mucositisSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2009-014870-16-HU
• Lead Sponsor: BioAlliance Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-23
• Last Update Posted: 19 January 2015

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.Prior neoadjuvant chemotherapy allowed provided that, the patient did not experience a WHO grade > 2 oral mucositis during the neoadjuvant therapy.
5.Patient eligible to receive concurrent chemo-radiation defined as :
a.A continuous course of conventional external beam irradiation (IMRT 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 combined with platinum based chemotherapy on a weekly or tri-weekly cycles
b.Planned radiation treatment fields must include at least two oral tissue sites (among right or left buccal mucosa, floor of the mouth, tongue, right or left soft palate) with each site receiving a total of 50 Gy or a maximum of 70 Gy. The radiation treatment plan will be reviewed by a designated radiation oncologist.
6.ECOG performance status = 2
7.Screening laboratory tests
a.Haemoglobin = 10g/dL (100 g/L)
b.Absolute neutrophil counts = 1500 cells/mm3 (1.5 109 cells/L)
c.Platelets = 100.000/mm3 (100 109/L)
d.Conjugated bilirubin = 2 times Upper Limit of Normal (ULN)
e.Serum AST and ALT = 3 ULN
f.Negative serum pregnancy test
8.Women of child bearing potential must have effective contraception method (oral or device)
9.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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

1.Tumours of the lips, sinuses, salivary glands
2.Prior radiation of the head and neck area
3.Curative surgery less than 2 weeks or more than 15 weeks prior to the initiation of RT-CT
4.Presence of active infectious disease
5.Presence of active oral infectious disease, including oropharyngeal candidiasis and/or orofacial herpes
6.Presence of oral mucositis
7.Known or suspected chronic viral diseases including HIV
8.Systolic blood pressure <100 mmHg and/or diastolic blood pressure <50 mmHg
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.Subjects with orthostatic hypotension, defined by a decrease of systolic BP and/or diastolic BP above 20 mmHg when the patient stands up
12.Renal insufficiency defined as creatinine blood level > 1.5ULN
13.Ongoing heavy alcohol consumption (>100g alcohol/day)
14.Administration of any concomitant treatment likely to interfere with clonidine (see section 6.4)
15.Known hypersensitivity to clonidine, history of allergy or intolerance to milk proteins or any other component of the product
16.Presence of severe or uncontrolled depression
17.Pregnant or breast-feeding women
18.Inability to give informed consent or comply with study requirements
19.Unable or unwilling to comply with follow-up visits
20.Participation to a clinical trial within 30 days prior to randomization and during the entire duration of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified