Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy (NCT03743155) | Clinical Trial Compass
UnknownPhase 2
Clinical Trial to Evaluate the Effect and Safety of MSV in Xerostomy
Spain10 participantsStarted 2018-12-15
Plain-language summary
Phase II not controlled, open-label, prospective, single center clinical trial
Who can participate
Age range
18 Years – 75 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
. Patients from 18 to 75 years old of both sexes.
. Biochemical analysis without significant alterations which could contraindicate the treatment.
. Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a.
. 2 years of follow-up without recurrence.
. Reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0.05- 0.20 ml / min.
. Grade 1-3 xerostomy as assessed by the grading scale.
. The patient is able to understand the nature of the study.
. Written informed consent of the patient
Exclusion criteria
. Participation in another clinical trial in the 3 months prior to his/her inclusion.
. Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion).
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
Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire
Timeframe: 24 months
2
Changes in the characteristics and degree of discomfort of xerostomia.
Timeframe: 24 months
3
Sialometry results
Timeframe: 24 months
4
Restoration of the glandular structure.
Timeframe: 24 months
5
Restoration of the glandular structure.
Timeframe: 24 months
6
Restoration of the glandular structure.
Timeframe: 24 months
7
Measurement of submaxillary gland functionalism changes based on Gammagraphy
. Patients with positive serologies for HIV, lues and hepatitis with positive viral load.
. History of cancer in the last 2 years. History of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa.
. Xerogenic medication in progress.
. Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc.
. Local infection.
. Pregnancy or pregnancy planned within the next 2 years.