E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
head and neck cancer patients treated with chemo-radiotherapy |
hoofdhalskankerpatienten die behandeld worden met chemoradiatie |
|
E.1.1.1 | Medical condition in easily understood language |
head and neck cancer patients treated with a combination of chemotherapy and radiotherapy |
hoofdhalskankerpatienten die behandeld worden met chemoradiatie |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067821 |
E.1.2 | Term | Head and neck cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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bestuderen van:
- de invloed van mucositis op de absorptie van sublingaal fentanyl, bij patienten met hoofdhalskanker, die behandeld worden met chemoradiatie
|
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E.2.2 | Secondary objectives of the trial |
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.
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- de invloed van xerostomie op de absorptie van sublinguaal fentanyl
- de relatie tussen absorptie van sublinguaal fentanyl en de lokale radiotherapie dosis |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
- patienten met hoofdhalskanker waarvoor behandeling met chemoradiatie
- informed consent
- leeftijd ouder of gelijk aan 18
- geen ernstige psychiatrische ziekte, verwardheid of mentale retardatie |
|
E.4 | Principal 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 |
- gebruik van fentanyl 1wk voor inclusie in the studie (andere opiaten mogen wel)
- intolerantie voor opioiden
- eerdere allergische reactie op opioiden
- het gebruik van cytochrome P450 (CYP) inhibitors of inducers is op zich geen contra-indicatie. Maar de pt moet dit gebruik niet veranderen gedurende de sampling periode. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Auc, clearance |
- Auc, klaring |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- pain scores
- CTC toxicity scores
- xerostomia scores |
- pijn scores
- CTX tox scores
- xerostomie scores |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
eigen controle |
own control |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
13 patients will be included and analysis will be performed on 10
patients. |
13 patienten zullen geincludeerd en geanalyseerd worden. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |