Absorption of sublingual delivered fentanyl (Abstral®) in head and neck cancer patients treated with curatively aimed chemo-radiotherapy

Conditions: head and neck cancer patients treated with chemo-radiotherapy
MedDRA version: 16.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-003707-18-NL

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 13

Inclusion Criteria

- patients with head and neck cancer and planned treatment with chemo-radiotherapy
- written informed consent
- age > or = 18
- no serious psychiatric illness, confusion or intellectual disability
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 13
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- use of fentanyl medication within one week before inclusion in the study (other opioid and non-opioid analgesics are allowed)
- opioid intolerance
- former allergic reactions to opioids
- the use of cytochrome P450 (CYP) inhibitors or inducers is not an exclusion criterion by itself. However, the patient should not change its use during the sampling periods, to exlude altered CYP function on the PK of Abstral

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary endpoint<br>-The influence of mucositis on the plasma pharmacokinetics (primary AUC) of sublingually delivered fentanyl (Abstral ®) in patients during periods with and without mucositis. <br><br><br><br>;Secondary Objective: Secondary endpoint<br>-The influence of xerostomia on the pharmacokinetics of sublingually delivered fentanyl (Abstral ®) in patients during periods with and without xerostomia.<br>-The relation between absorption of sublingually delivered fentanyl and the local radiation dose.<br>;Primary end point(s): - Auc, clearance;Timepoint(s) of evaluation of this end point: 3 years

Secondary Outcome Measures