Absorption of sublingually delivered fentanyl (Abstral®) in head and neck cancer patients treated with curatively aimed chemo-radiotherapy
Recruiting
- Conditions
- head and neck cancer, radiochemotherapy, mucositis, fentanyl
- Registration Number
- NL-OMON26436
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
•patients with histologically confirmed head and neck cancer and planned treatment with radiotherapy in combination with cisplatin chemotherapy
•written informed consent
•18 years or older
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
•serious psychiatric illness, confusion or intellectual disability
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fentanyl pharmacokinetics (i.e.clearance, AUC).
- Secondary Outcome Measures
Name Time Method -Side effects conform the CTCAE 4.03 toxicity criteria<br /><br>-Mucositis according the CTCAE 4.03 toxicity criteria and the OMAS<br /><br>-Painscores, scored with the NRS (in patients with pain)<br /><br>-Xerostomia using the GRIX<br /><br>