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.
Former radiotherapy for squamous cell carcinoma, or adenocarcinoma, of the nasal sinus, larynx, pharynx, and oral cavity
WHO Performance status 0-1
Presence of xerostomia daily
UWS of 0.05 mL/min to 0.5 ml/min
Any malignant cancer diagnosis excluding head and neck cancers
Xerogenic medications at inclusion
Penicillin or streptomycin allergy assessed by health personnel
Any other previous or active disease of the salivary glands (e.g. Sjögren's Disease, sialolothiasis)
Parallel
ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
DrugSuspended in 10% DMSO. Manufactured by OUH CELL BENCH in Odense, Denmark.
Placebo
DrugSterile isotonic saline water
Unstimulated whole salivary flow rate
Unstimulated whole salivary flow rate measured in mL/min
Stimulated whole salivary flow rate
Stimulated whole salivary flow rate measured in mL/min
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.
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
Immune response
Measured by positivity of de novo drug specific antibodies (binary outcome)
Incidence of treatment-related adverse events and serious adverse events
Evaluated by serious adverse events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), treatment-related adverse events, and deaths.
Outcome 1 to 6 assessed at long term follow-up
5-point transition scale for determining the minimal important difference (evaluated at 8 months)
The 5-point transition scale is critical in the exploratory secondary objective of developing Minimal Important Differences (MIDs) for all the outcome measures applied in the trial because it provides a subjective, patient-centered anchor to assess meaningful change. The scale, which typically ranges from "much worse" to "much better," captures participants' perceptions of change in their condition over time. By linking participants' responses on this scale to corresponding changes in clinical outcome measures, the transition scale helps identify the smallest change in those measures that is considered important or beneficial by the participants themselves. This subjective assessment of change is essential for establishing MIDs, as it ensures that the derived thresholds reflect clinically relevant improvements or deteriorations from the patients' perspectives.
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Christian von Buchwald
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
