Phase 2
N=30
Mesenchymal Stemcells for Radiation Induced Xerostomia
Xerostomia
Bottom Line
View on ClinicalTrials.gov: NCT02513238 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Number of Participants With Adverse Events as a Measure of Safety — 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mesenchymal stem cell (Drug); Isotonic NaCl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rigshospitalet, Denmark
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety |
0; 0 | — |
Summary
The current study aims to assess the safety and feasibility of the injection of autologous adipost tissue derived MSCs on radiation-induced salivary gland hypofunction and xerostomia in head and neck cancer participants. The project can potentially help to develop a clinically relevant treatment option for the growing number of patients suffering from xerostomia after radiotherapy. The development of new therapies is especially important, since only sub-optimal symptomatic treatments are currently available and the symptom of xerostomia greatly reduces the quality of life.
Eligibility Criteria
Inclusion Criteria
Previous radiotherapy for HPV-positive oropharyngeal head and neck cancer with bilateral irradiation of the neck.
- 2 years follow-up without recurrence
- Clinically reduced salivation and hyposalivation, evaluated by a screening
- Unstimulated salivary flow rate between less than 0.2ml/min and above 0.05ml/min
- Only participants with previous T1-T2 and N0, N1 or N2a.
- Informed consent
- Grade 1-3 xerostomia as evaluated by the UKU side effect rating scale
Exclusion Criteria
- Any cancer in the previous 2 years
- Xerogenic medications
- Any other diseases of the salivary glands, e.g. Sjögrens syndrome, sialolithiasis, etc.
- Pregnancy or planned pregnancy within the next 2 years
- Breastfeeding
- Any other disease/condition judged by the investigator to be grounds for exclusion
- Treatment with anticoagulant that cannot be stopped during the intervention period.
Data sourced from ClinicalTrials.gov (NCT02513238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.