A Single-centre, Double-blinded, Randomised, Placebo-controlled, Phase II Study to Investigate the Safety and Efficacy of Mesenchymal Stem Cell for Radiation-induced Hyposalivation and Xerostomia in Previous Head and Neck Cancer Patients (MESRIX-III)

CVB2018-1

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 of life of the patients. Radiotherapy is a key component for approximately 80% of all patients with head and neck cancer and despite the enormous improvement in ionizing radiotherapy, the radiation still leads to significant ionizing of healthy tissue, including the radiation-sensitive salivary glands. Salivary glands suffer severe damage from radiation, and as these cells are the principal sites of fluid secretion one of the most prevalent side effect of irradiation for head and neck cancer is hyposalivation and dry mouth syndrome, xerostomia. Xerostomia leads to debilitating oral disorders and major implication for the overall quality of life, including social life and professional life. Currently, only symptomatic treatment is available to patients suffering from xerostomia, and therefore there is an immense, unmet need for new treatment strategies for hyposalivation and xerostomia. Stem cells have been identified as a potential treatment modality for a wide variety of disorders by their ability to differentiate into many functional cell types, and stem cells have been suggested as an approach to restoring the function of salivary glands after radiotherapy damage. The purpose of the study is to assess the efficacy and safety of the injection of stem cells from healthy donors on radiation-induced salivary gland hypofunction and xerostomia in previous head and neck cancer patients. The project can potentially help to develop a clinically relevant treatment option for the growing number of patients suffering from xerostomia after irradiation. The development of new therapies is especially meaningful since only sub-optimal, symptomatic treatments are currently available, and since the symptom of xerostomia immensely reduces quality of life.

2021-02-09

2024-03-01

2024-03-01

Active (not recruiting)

Early phase I

120

Inclusion Criteria: 1. Age between 18-70 years 2. Previous radiotherapy +/- chemotherapy for head and neck cancer 2 years' follow-up without recurrence 3. Clinically reduced salivation and hyposalivation, evaluated by a screening 4. Unstimulated salivary flow rate between 0.2 milliliter(mL)/minut (min) and 0.05 mL/min 5. Grade 1-3 xerostomia as evaluated by the UKU side effect rating scale 6. World Health organization (WHO) Performance status (PS) 0-1 59 7. Informed consent Exclusion Criteria: 1. Any cancer in the previous 4 years (not including the head and neck cancer and basocellular carcinomas) 2. Xerogenic medications 3. Penicillin or Streptomycin allergy 4. Any other diseases of the salivary glands, e.g. Sjögren's syndrome or sialolithiasis 5. Previous submandibular gland surgery 6. Previous treatment with any type of stem cells in the saliva glands 7. Pregnancy or planned pregnancy within the four months study period 8. Breastfeeding 9. Smoking within the previous 6 months. 10. Alcohol abuse (consumption must not exceed 7 units/week for women and 14 units/week for men (Danish National board health alcohol guidelines) 11. Any other disease/condition judged by the investigator to be grounds for exclusion

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2023-09-14