Stemcell treatment of drymouth after radiation therapy of HPV induced cancer in the tonsils or base of tongue

Phase 1

Conditions: The study will include participants with xerostomi (InternationalClassification of Diseases-10: DQ 838A) and oropharyngeal cancer (DC 10).
MedDRA version: 17.1Level: LLTClassification code 10031103Term: Oropharyngeal cancer stage unspecifiedSystem Organ Class: 100000004864
MedDRA version: 17.1Level: LLTClassification code 10048223Term: XerostomiaSystem Organ Class: 100000004856
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2014-004349-29-DK

Lead Sponsor: Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Previous radiotherapy for HPV-positive oropharyngeal head and neck cancer with bilateral irradiation of the neck.
•2 years follow-up without recurrence
•Clinically reduced hyposalivation and hyposalivation, evaluated by a screening
oUnstimulated salivary flow rate between less than 0.2ml/min and above 0.05ml/min
•Only participants with previous T1-T2 and N0, N1 or N2a.
•Informed consent
•Grade 1-43 xerostomia as evaluated by the UKU side effect rating scale

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Any cancer in the previous 2 years
•Xerogenic medications
•Any previous other diseases in of the salivary glands, e.g. Sjögrens syndrome, sialolithiasis, etc.
•Pregnancy or planned pregnancy within the next 2 years
•Breastfeeding
•Any other disease/condition judged by the investigator to be grounds for exclusion
•Treatment with anticoagulant that cannot be stopped during the intervention period.