Mesenchymal Stemcells for Radiation Induced Xerostomia
30 participantsStarted 2015-08-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Adverse Events as a Measure of Safety