Status:
UNKNOWN
Safety and Efficacy of Mesenchymal Stem Cell for Radiation-induced Hyposalivation and Xerostomia in Previous Head and Neck Cancer Patients
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet
The Cell Therapy Facility, The Blood bank, Dept. of Clinical Immunology, 2034, Rigshospitalet, Denmark
Conditions:
Xerostomia Following Radiotherapy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The incidence of head and neck cancer is increasing in the Western World, including Denmark. Cancer of the head and neck and its treatment often have a detrimental and lifelong impact on the quality o...
Detailed Description
Background: Xerostomia is the diagnosis of the subjective feeling of dry mouth. Xerostomia can coexist with or exist without a reduced production of saliva, although xerostomia is first perceived whe...
Eligibility Criteria
Inclusion
- Age between 18-70 years
- Previous radiotherapy +/- chemotherapy for head and neck cancer 2 years' follow-up without recurrence
- Clinically reduced salivation and hyposalivation, evaluated by a screening
- Unstimulated salivary flow rate between 0.2 milliliter(mL)/minut (min) and 0.05 mL/min
- Grade 1-3 xerostomia as evaluated by the UKU side effect rating scale
- World Health organization (WHO) Performance status (PS) 0-1 59
- Informed consent
Exclusion
- Any cancer in the previous 4 years (not including the head and neck cancer and basocellular carcinomas)
- Xerogenic medications
- Penicillin or Streptomycin allergy
- Any other diseases of the salivary glands, e.g. Sjögren's syndrome or sialolithiasis
- Previous submandibular gland surgery
- Previous treatment with any type of stem cells in the saliva glands
- Pregnancy or planned pregnancy within the four months study period
- Breastfeeding
- Smoking within the previous 6 months.
- Alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines)
- Any other disease/condition judged by the investigator to be grounds for exclusion
Key Trial Info
Start Date :
February 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04776538
Start Date
February 9 2021
End Date
March 1 2024
Last Update
September 14 2023
Active Locations (1)
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1
Christian von Buchwald, MD, DMSc, Professor
Copenhagen, Denmark, 2100