First objective: To study the influence of mucositis on the absorption of sublingually delivered fentanyl (Abstral ®) in head and neck cancer patients treated with chemoradiotherapy. Secondary objectives: to study the influence of xerostomia on the…
ID
Bron
Aandoening
head and neck cancer, radiochemotherapy, mucositis, fentanyl
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Fentanyl pharmacokinetics (i.e.clearance, AUC).
Achtergrond van het onderzoek
SUMMARY
Rationale: The majority of head and neck cancer patients treated with curatively aimed chemoradiotherapy suffer from severe mucositis. Mucositis can cause different problems e.g. pain and difficulties with swallowing. Furthermore, xerostomia often occurs after chemoradiotherapy, due to destruction of the salivary glands. From the third week of radiotherapy, oral pain is getting worse, and will require analgesics. Mucositis is increasing in the weeks following and worst at the end of the radiotherapy treatment. Most patients need strong opioids for the treatment of the pain caused by mucositis. Fentanyl is a widely used strong opioïd and is highly lipophilic. Nowadays there are several immediate release fentanyl products for the treatment of breakthrough pain. One of them is sublingually delivered fentanyl, (Abstral ®). Abstral is placed directly under the tongue to be absorbed by the mucosa. It is unknown if mucositis and xerostomia will influence the absorption of sublingual fentanyl and thereby its potential efficacy in case of breakthrough pain.
Objective: First objective: To study the influence of mucositis on the absorption of sublingually delivered fentanyl (Abstral ®) in head and neck cancer patients treated with chemoradiotherapy. Secondary objectives: to study the influence of xerostomia on the absorption of sublingually delivered fentanyl (Abstral®) in these patients 6 weeks after treatment with chemoradiotherapy; to study the relation between the dose of radiotherapy administered sublingually and the changes in pharmacokinetics of sublingually delivered fentanyl (Abstral®); and to study the effect of sublingually delivered fentanyl (Abstral®) on pain intensity in these patients before, during and after chemoradiotherapy.
Doel van het onderzoek
First objective: To study the influence of mucositis on the absorption of sublingually delivered fentanyl (Abstral ®) in head and neck cancer patients treated with chemoradiotherapy. Secondary objectives: to study the influence of xerostomia on the absorption of sublingually delivered fentanyl (Abstral®) in these patients 6 weeks after treatment with chemoradiotherapy; to study the relation between the dose of radiotherapy administered sublingually and the changes in pharmacokinetics of sublingually delivered fentanyl (Abstral®); and to study the effect of sublingually delivered fentanyl (Abstral®) on pain intensity in these patients before, during and after chemoradiotherapy.
Onderzoeksopzet
4 different time points: 24-72 hrs before the start of the chemoradiotherapy (T=0), 24-72 hrs before the planned start of the 2nd gift of chemotherapy (T=1) , 24-72 hrs before the planned start of the 3rd gift of chemotherapy (T=2) and six weeks after the end of the chemoradiotherapy (T=last).
Onderzoeksproduct en/of interventie
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 the chemoradiotherapy (T=0), 24-72 hrs before the planned start of the 2nd gift of chemotherapy (T=1) , 24-72 hrs before the planned start of the 3rd gift of chemotherapy (T=2) and six weeks after the end of the chemoradiotherapy (T=last).
Publiek
Department of Medical Oncology<br>
Groene Hilledijk 301
E.J.M. Kuip
Rotterdam 3075 EA
The Netherlands
e.kuip@erasmusmc.nl
Wetenschappelijk
Department of Medical Oncology<br>
Groene Hilledijk 301
E.J.M. Kuip
Rotterdam 3075 EA
The Netherlands
e.kuip@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
•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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
•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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4741 |
NTR-old | NTR4995 |
Ander register | : MEC 2013-550 |