Stem cell treatment of dry mouth after radiation therapy of head and neck cancer

Phase 1

• Conditions: The trial will include participants with Xerostomia (International Classification of Diseases-10: DQ 838A) who have been treated with raditherapy for a head and neck cancer prevoiusly.; MedDRA version: 20.1Level: PTClassification code 10013781Term: Dry mouthSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.0Level: LLTClassification code 10048223Term: XerostomiaSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.0Level: HLTClassification code 10039420Term: Salivary gland therapeutic proceduresSystem Organ Class: 100000004865; MedDRA version: 20.0Level: HLGTClassification code 10039404Term: Salivary gland conditionsSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 21.1Level: PTClassification code 10039390Term: Salivary gland atrophySystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2018-000348-24-DK
• Lead Sponsor: Department of Otorhinolaryngology, Head and Neck Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-27
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Previous radiotherapy for head and neck cancer
2 years follow-up without recurrence
Clinically hyposalivation: unstimulated salivary flow < 0.2ml /ml and above 0.05 ml/min
Informed consent
Grade 1-3 Xerostomia evaluated by the UKU side effect rating scale
Age 18-75
WHO performance score 0-1

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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Any cancer in the previous 2 years ( not including OPSCC and basocellular carcinoma)
Smoking within the last 6 months
Xerogenic medications within the last 3 months
Any current or previous other diseases in the salivary glands (Sjögrens syndrome, Sialolithiasis etc.)
Pregnancy or planned pregnancy with the next 2 years
Breastfeeding
Any other disease/condition juged by the investigator to be grounds for exclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified