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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003707-18-NL

Enrollment

Registered

2013-12-18

Start date

2014-04-22

Completion date

Unknown

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck cancer patients treated with chemo-radiotherapy MedDRA version: 16.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Abstral Product Name: Abstral Product Code: PL 16508/0031 Pharmaceutical Form: Sublingual tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Secondary end point(s): - pain scores - CTC toxicity scores - xerostomia scores;Timepoint(s) of evaluation of this end point: 3 years	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026