Radiation-induced salivary glandatrophy
Conditions
Interventions
Harvesting of labial gland and transplantation of processed cells
Sponsors
Kasamatsu Atsushi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria Patients who visited the Department of Dentistry and Oral-Maxillofacial Surgery at Chiba University Hospital and are scheduled to undergo radiation therapy for head and neck cancer. Able to undergo lip gland extraction. Prohibition of other treatment methods, including oral administration of pilocarpine hydrochloride, mouthwash with moisturizer, oral saliva substitutes, and use of artificial saliva. Male or female aged over 20 years at the time of consent. The participant is able to use contraception during the study period. Obtained informed consent regarding the administration of cells and participation in this study. Preservation of major organ functions. Must meet the following blood test criteria: White blood cell count (x 10^3/microL) over 3.5, under 12.0 Platelet count (x 10^3/microL) over 100 Number of neutrophils (x 10^3/microL) over 2.0 Hemoglobin (g / dL ) over 9.0 Total bilirubin (mg / dL ) under 1.8 AST (GOT ) (IU / L ) under 30 AL T (GPT ) (IU / L ) under 23 Cr (mg / dL ) under male 1.56 female 1.2 CCr (e-GFR also acceptable ) (mL / min) over 60
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patients with peptic ulcer. Patients with serious blood abnormalities, liver disorder, kidney disorder, or cardiac dysfunction. Patients with severe hypertension. Patients taking anticoagulants. Patients with bleeding or a tendency to bleed. Patients with congestive heart failure. Pregnant women or women with a possibility of pregnancy. Breastfeeding women. Patients with complications of psychosis or psychiatric symptoms. Patients receiving continuous systemic administration (oral or intravenous) of steroids. Patients or family members with autoimmune diseases. Patients infected with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), human T-cell leukemia virus type 1 (HTLV-1), or parvovirus B19 (HPV-B19). Patients with a history of anaphylactic reaction. Patients with a positive atelocollagen intradermal test. Patients whose cancerous part or safety zone includes the lip and gland collection site. Other patients deemed inappropriate as subjects by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Adverse Events Evaluation of adverse events, including abnormalities in laboratory tests Frequency of adverse events Duration of adverse events Severity of adverse events Necessity of treatments for adverse events Relationship between salivary gland cell transplantation and adverse events Detailed descriptions of adverse events should be recorded in the Case Report Form (CRF) Monitoring of adverse events will be assessed using CTCAE version 5.0 (Japanese translation, JCOG version) | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness of Salivary Gland Cell Transplantation 1. Salivary Secretion Test Salivary secretion is measured using the Gum Test and Saxon Test. (If patients do not have molar occlusion, only the Saxon Test should be performed.) Gum Test: The patient chews gum for 10 minutes and then spits saliva into a cup. The total amount is measured. A total volume of less than 10 mL indicates salivary secretion disorder. Saxon Test: The patient chews gauze for 2 minutes, and the total weight of the gauze is measured. A total weight gain of less than 2 g indicates salivary secretion disorder. Salivary secretion is evaluated before and after salivary gland cell transplantation using both tests at 1, 3, and 6 months, and 1 year after transplantation, to assess the long-term effects. 2. Improvement of Subjective Symptoms (Dry Mouth) The degree of dry mouth symptoms is assessed using the Visual Analog Scale (VAS) method through interviews before and after treatment. Numerical values obtained from the VAS are used for statistical analysis. VAS Method: A 10 cm line is displayed, with the left end indicating "no symptoms" and the right end indicating "the most severe symptoms." The subjective severity of dry mouth is quantified by measuring the length from the left end to the point marked by the patient. | — |
Countries
Japan
Contacts
Public ContactReo Fukushima
Chiba University Hospital
Outcome results
None listed