E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The trial will include participants with Xerostomia ( International Classification of Diseases-10: DQ 838A) |
Studiet vil inkludere forsøgsdeltagere med xerostomi (DQ 838A) |
|
E.1.1.1 | Medical condition in easily understood language |
This trial will include participants with dry-mouth syndrome after radiotherapy for cancer in the tonsils or base of the tongue |
Studiet vil inkludere forsøgsdeltagere med mundtørhed opstået efter strålebehandling for kræft i mundsvælget ( kræft i mandlerne eller/og tungerod) |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048223 |
E.1.2 | Term | Xerostomia |
E.1.2 | System Organ Class | 100000004856 |
|
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 |
The objective is to examine if injection of allogeneic mesenchymal stem cells into the parotid amd submandibular gland is safe and will improve the salivary gland function after radiation-induced damage |
Formålet er at undersøge om donor fedtstamceller er sikre indsprøjte i øre- og kæbespytkirtlerne og om det vil forbedre de store spytkirtlers funktion hos patienter med beskadigelse i disse kirtler sekundært til strålebehandlig for cancer |
|
E.2.2 | Secondary objectives of the trial |
Changes in saliva production, changes in quality of life and monitorering immune response to allogeneic stem cell treatment |
Ændring i spytproduktion, ændring i livskvaliteten og registrering af eventuel immun respons på modtagelse af donor stamceller. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Informed consent
Previous radiotherapy for oropharyngeal OPSCC cancer stage I-II
2 years of follow-up without recurrence
Clinically hyposalivation:unstimalted salivary flow < 0.2 ml/min and above 0.05 ml/min
Grade 1-3 Xerostomia evaluated by UKU side effect rating scale |
Underskrevet informeret samtykke
Tidligere strålebehandling for planocellulær mundsvælgkræft stadie I-II
2 års påfølgning uden recidiv
Klinisk mundtørhed og nedsat spytproduktion fra de store spytkirtler - evalueret ved anerkendte screeningsmetoder |
|
E.4 | Principal exclusion criteria |
Any cancer in the previous 2 years ( not including basocellular carcinoma and OPSCC)
Smoking
Xerogenic medications
Any current or previous otjer diseases in the salivary glands ( e.g Sjögrens syndrome, Sialolithiasis)
Pregancy or planned pregnancy within the next 2 years
Breastfeeding
Any other disease/condition juged by the investigator to be grounds for exclusion |
Alle kræftformer de senest 2 år ( fraset mundsvælgkræft og basalcelle hudkræft)
Medicinsk behandling af mundtørhed
Medicinsk behandling med mundtørhed som bivirkning
Andre spytkirtel sygdomme eller tidligere operation
Graviditet eller planlagt graviditet inden for de næste 2 år
Igangværende amning
Anden sygdom som vurderes uhensigtsmæssig i forhold til studiet |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety
Change in unstimulated salivary flow rate |
Sikkerhed
Ændring i ustimuleret spytsekretion |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 1 day, one month and four months |
Efter 1 døgn, 1 måned og 4 måneder |
|
E.5.2 | Secondary end point(s) |
Change in quality of life
Change in salivary gland function
Immune reponse to allogeneic ASC
Change in composition of saliva |
Ændring i livskvalitet
Ændring i de store spytkirtlers funktion
Immunrespons sekundært til behandling med donor stamceller
Ændring i spyttets sammensætning |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Safety and blood samples after 1 day, one month and 4 months
Salivary flow rates after one month and 4 months
Quality of life questionnaires after 4 months
|
Sikkerhed vurderes efter 1 døgn, 1 måned og 4 måneder
Blodprøver tages efter 1 døgn, 1 måned og 4 måneder
Livskvalitespørgeskemaer efter 1 måned og 4 måneder
Spytflow efter 4 måneder |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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) | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | No |
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.8.3 |
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
|
LVLS |
Sidste besøg, sidste deltager |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |