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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26436

Enrollment

Registered

2015-02-18

Start date

2014-12-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

head and neck cancer, radiochemotherapy, mucositis, fentanyl

Interventions

Patients will be given a single dose of Abstral® 200 mcg sublingually. Pharmacokinetics of sublingually delivered fentanyl will be measured at 4 different time points: 24-72 hrs before the start of t

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Fentanyl pharmacokinetics (i.e.clearance, AUC).	—

Secondary

Measure	Time frame
-Side effects conform the CTCAE 4.03 toxicity criteria -Mucositis according the CTCAE 4.03 toxicity criteria and the OMAS -Painscores, scored with the NRS (in patients with pain) -Xerostomia using the GRIX	—

Contacts

Public ContactE.J.M. Kuip

Erasmus Medical Center Department of Medical Oncology Groene Hilledijk 301

e.kuip@erasmusmc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)