Absorption of sublingually delivered fentanyl (Abstral) in head and neck cancer patients treated with curatively aimed chemo-or bioradiotherapy

Completed

• Conditions: bio-radiotherapy; chemo-radiotherapy; head and neck cancer; 10027655

• Registration Number: NL-OMON41370
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 13

Inclusion Criteria

- patients with head and neck cancer and planned treatment with chemo-radiotherapy or radiotherapy in combination with cetuximab
- written informed consent
- age > or = 18
- no serious psychiatric illness, confusion or intellectual disability

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Fentanyl pharmacokinetics (i.e.clearance).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- side effects according the CTC toxicity criteria<br /><br>- mucositis according the CTC toxicity criteria and the OMAS<br /><br>- Painscores according the NRS (in patients with pain)<br /><br>- Xerostomia scores according the GRIX</p><br>