Dry mouth leads to debilitating symptoms 24/7. The two primary causes for dry mouth are Sjögrens disease and after radiotherapy of a head and neck cancer. Former clinical trials have investigated mesenchymal stem cell treatment for dry mouth with promising results. However, few of the participants evolved normal salivary flow rate. Therefore, in this randomized clinical trial, two treatments of mesenchymal stem cells are administered, 4 months apart. This has not been done before. The hypothesis is that two treatments of mesenchymal stem cells results in a higher salivary flow rate and ameliorate symptoms from dry mouth.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Suspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark.
Sterile isotonic saline water
Unstimulated whole salivary flow rate
Unstimulated whole salivary flow rate measured in mL/min
Time frame: T=0 months, T=4 months and T=8 months (primary endpoint assessed after 8 months)
Stimulated whole salivary flow rate
Stimulated whole salivary flow rate measured in mL/min
Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Patient-Reported Outcome of xerostomia: The Groningen Radiotherapy-Induced Xerostomia questionnaire (GRIX).
For evaluation of the participants´ perception of xerostomia, the participants will answer validated questionnaires in Danish.
Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Patient-Reported Outcome of xerostomia: The European organization for research and treatment of cancer quality of life questionnaire, head and neck-35 (EORTC QLQ-H&N35).
For evaluation of the participants´ perception of xerostomia, the participants will answer validated questionnaires in Danish. Patients will fill out the EORTC-QLQ- H\&N35 (evaluates overall implications of the xerostomia) for the following domains: * HNDR: dry mouth * HNSS: sticky saliva * HNSW: swallowing
Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Immune response
Measured by positivity of de novo drug specific antibodies (binary outcome)
Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
Patient Reported Outcome: Goal Attainment Scale (GAS)
Goal attainment Scale (GAS) was developed in 1968 for assessing outcomes in mental health and has since been updated\[36\]. Now it is used in a wide variety of settings. It is a qualitative patient reported outcome measure. GAS can be beneficial in drug trials where patients have heterogenic symptoms of the disease\[37\]. The patient, supported by the health professional, picks 3 personal goals to be measured throughout the study period. The goals must be related to the disease and treatment. In this study 3 goals could be: 1. Ability to sleep better at night, ability to eat more solid foods, and less mouth pain. The goals are evaluated at baseline and at each follow up, following the scoring system seen in figure 1. Statistics are calculated from T-scores.
Time frame: T=0 months, T=4 months, T=8 months (Key secondary endpoint assessed after 8 months).
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