Xerostomia Due to Radiotherapy
Conditions
Brief summary
Phase II not controlled, open-label, prospective, single center clinical trial
Detailed description
* Determine changes in the xerostomia characteristics and discomfort degree by means of questionnaires addressed to the physician and subject of study. * Determine the volume of submaxilar saliva without stimulation and with stimulation by sialometry (SL). * Detect changes in volume, vascularization and fibrosis of submaxillary glands based on magnetic resonance imaging (MRI) with contrast. * Detect changes of submaxillary gland functionalism based on Gammagraphy (GF).
Interventions
BIOLOGICALmesenchymal cells
Autologous bone marrow aspiration is used as a cellular source to obtain MSVs and is subjected to the protocolized anticoagulant procedure. After checking the perfect condition of the shipment and the correct completion of the documentation that accompanies it, the processing of the bone marrow will be carried out. The processing of the bone marrow will be done in the Cell Therapy Unit of the IBGM under NCF, within 24 hours of the completion of the aspiration
Sponsors
Institut de Terapia Regenerativa Tissular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single arm due to not alternative treatment exist
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients from 18 to 75 years old of both sexes. 2. Biochemical analysis without significant alterations which could contraindicate the treatment. 3. Bilateral radiotherapy of the previous neck due to neoplasia in states T1-T2 and N0, N1 and N2a. 4. 2 years of follow-up without recurrence. 5. 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. 6. Grade 1-3 xerostomy as assessed by the grading scale. 7. The patient is able to understand the nature of the study. 8. Written informed consent of the patient
Exclusion criteria
1. Participation in another clinical trial in the 3 months prior to his/her inclusion. 2. Present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion). 3. Patients with positive serologies for HIV, lues and hepatitis with positive viral load. 4. 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. 5. Xerogenic medication in progress. 6. Other diseases of the salivary glands, for example, Sjögren's syndrome, sialolithiasis, etc. 7. Local infection. 8. Pregnancy or pregnancy planned within the next 2 years. 9. Breastfeeding. 10. Treatment with anticoagulants (not interruptible in MO or application). 11. Any other illness or condition that is grounds for exclusion for the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the characteristics and degree of discomfort of xerostomia trough OHIP questionnaire | 24 months | Absolute and relative change of the score of the OHIP Questionnaire (OHIP-14-sp) |
| Changes in the characteristics and degree of discomfort of xerostomia. | 24 months | Absolute and relative change of the score of the EVA Questionnaire |
| Sialometry results | 24 months | Absolute and relative change in the volume of saliva (ml / min) submaxillary |
| Restoration of the glandular structure. | 24 months | Changes in the glandular structure (volume) (MRI with contrast) |
| Measurement of submaxillary gland functionalism changes based on Gammagraphy | 24 months | Measurement of submaxillary gland functionalism changes based on Gammagraphy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AEs and SAEs | 24 months | Determination of the Safety of the proposed procedure, recording adverse events (AEs) and serious adverse events (SAEs). It will be considered as early safety measures: Pain at the site of injection, submaxillary swelling, duration of submaxillary swelling in days, oral discomfort, infection |
Countries
Spain
Contacts
Primary ContactLluis Orozco, MD
Backup ContactRoberto Soler Rich, MD
Outcome results
None listed