xerostomia caused by radiation treatment
Conditions
Interventions
Intervention: injection of E-MNC to the submandibular gland
Intervention period: 1-year
Number of times of intervention: 1 time
Sponsors
Yoshinori Sumita
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are suffering form sever xerostomia caused by the radiotherapy for head and neck cancer. 2. Patients who have no recurrence of head and neck cancer more than 5 years after treatment. 3. Patients who complain the xerostomia and whose saliva flow rate is in the range of less than 10ml/10min. 4. Patients who are detected the salivary gland atrophy by CT examination.
Exclusion criteria
Exclusion criteria: 1. Hemoglobin concentration in peripheral blood 1) blood collection within 200ml male: less than 12.5g/dl of hemoglobin concentration femal: less than 12.0g/dl of hemoglobin concentration 2) blood collection with 200ml and over (within 240ml) male: less than 13.0g/dl of hemoglobin concentration femal: less than 12.5g/dl of hemoglobin concentration 2. Patients who had got salivary gland tumor as a primary disease. 3. Patients who have any cancer and sepsis. 4. Patients who suffer from severe endocrine metabolic disease and autoimmune disease. 5. Patients who are posiitive of sphilis, HBV-antigen, HCV-antigen, HTLV-1-antibody and HIV-antibody. 6. Patients who are judged as improper to join in this study by the principal investigator or co-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficay (improvement of saliva secreation and gland volume) | — |
Countries
Japan
Contacts
Public ContactYoshinori Sumita
Nagasaki University
Outcome results
None listed