Covid 19 Research using Clinical Trials (Home Page)
HP:0000217: XerostomiaHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (1)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug300 | Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells Wiki | 1.00 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 A Phase I Dose Escalation Trial of Mesenchymal Stromal Cells in Patients With Xerostomia After Radiation Therapy for Head and Neck Cancer
This is a single center, non-randomized, Phase I dose escalation study to assess the safety and tolerability of a single dose of autologous, bone marrow-derived, interferon gamma-stimulated Mesenchymal Stromal Cells (MSCs) injected into the submandibular glands of patients with radiation-induced xerostomia (dry mouth) following treatment for head and neck cancer (HNC).
NCT04489732 Xerostomia Following Radiotherapy Biological: Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells MeSH:Xerostomia
HPO:Xerostomia
Primary Outcomes
Description: Dose limiting toxicity is defined as 1) score > 5 on a standard pain scale of 1-10, or 2) any serious adverse event. The percentage of subjects experiencing DLT will be used to determine the maximum tolerated dose or maximum administered dose. That dose will be the recommended dose for a phase 2 trial (RP2D).
Measure: Percentage of subjects experiencing dose limiting toxicity (DLT) Time: Day 30 ± 10 days
Secondary Outcomes
Description: Whole saliva production rates will be measured under unstimulated and stimulated saliva collection conditions.
Measure: Change in Saliva production rate Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohort
Description: Salivary pH will be measured using a pH meter. The normal range of saliva pH is 6.2-7.6 .
Measure: Saliva composition analysis: Change in salivary pH Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohort
Description: ELISA will be used to quantify total protein concentration in saliva. The normal range of total protein in saliva is 2-5 mg/mL.
Measure: Saliva composition analysis: Change in total protein concentration in saliva Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohort
Description: The enzyme-linked immunosorbent assay (ELISA) will be used to quantify amylase concentration in saliva. The normal range of amylase concentration in saliva is 10-150 U/mL.
Measure: Saliva composition analysis: Change in amylase concentration in saliva Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohort
Description: ELISA will be used to quantify mucin concentration in saliva.The normal range of mucin concentration in saliva is 1,000-3,000 ug/mL.
Measure: Saliva composition analysis: Change in mucin concentration in saliva Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohort
Description: The University of Michigan Xerostomia Related Quality of Life (XeQOL) scale is a validated patient-reported assessment 15 item scale with 4 domains: physical functioning, pain/discomfort, personal/psychologic functioning, and social functioning. Participants will answer the questions on a scale of 1-5 (not a all, a little, somewhat, quite a bit, very much) for every item. Higher scores represent greater degree of symptoms.
Measure: Change in The University of Michigan Xerostomia Related Quality of Life (XeQOL) score Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohort
Description: The MDADI is a 20-item questionnaire designed for evaluating the impact of dysphagia on the quality of life of patients with head and neck cancer. The MDADI score ranges from 20-100 with a lower scale representing worse dysphagia.
Measure: Change in The MD Anderson Dysphagia Index (MDADI) score Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohort
Description: A Visual Analogue Scale questionnaire for subjective assessment of salivary dysfunction. The VAS xerostomia questionnaire is an 8-item questionnaire that provides a validated measure of the perception of dry mouth. Participants will be asked to mark their responses to each item by placing a vertical line on the 100-mm horizontal scale. The VAS ranges from 8-80 with a lower scale representing less dysphagia/symptoms
Measure: Change in Visual Analogue Scale (VAS) xerostomia score Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohort
Description: Salivary gland size measured by ultrasound imaging
Measure: Change in salivary gland size Time: at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohort
HPO Nodes
HP:0000217: Xerostomia
Genes 62
GSN FGFR3 PFN1 EDARADD SRSF2 CBL OPTN IRF5 LBR B2M DAO FGF10 CHMP2B ANG CAV1 C9ORF72 GLT8D1 VAPB CFAP410 UNC13A TET2 DCTN1 TBK1 PON2 PON1 NOD2 TREM2 SCN9A ANXA11 PPARGC1A NEFH HNRNPA1 SOD1 CHRM3 FIG4 ERBB4 UBQLN2 TAF15 PRPH CCR6 ASXL1 SQSTM1 EPHA4 ATXN2 VCP TARDBP FUS TP63 FGFR2 GLE1 FGF10 RUNX1 CHCHD10 MATR3 CCN2 NOD2 PON3 CLDN10 TP63 NEK1 CCNF HLA-DRB1 Protein Mutations 0
SNP 0
Primary Outcomes
Description: Dose limiting toxicity is defined as 1) score > 5 on a standard pain scale of 1-10, or 2) any serious adverse event. The percentage of subjects experiencing DLT will be used to determine the maximum tolerated dose or maximum administered dose. That dose will be the recommended dose for a phase 2 trial (RP2D).
Measure: Percentage of subjects experiencing dose limiting toxicity (DLT) Time: Day 30 ± 10 daysSecondary Outcomes
Description: Whole saliva production rates will be measured under unstimulated and stimulated saliva collection conditions.
Measure: Change in Saliva production rate Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: Salivary pH will be measured using a pH meter. The normal range of saliva pH is 6.2-7.6 .
Measure: Saliva composition analysis: Change in salivary pH Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: ELISA will be used to quantify total protein concentration in saliva. The normal range of total protein in saliva is 2-5 mg/mL.
Measure: Saliva composition analysis: Change in total protein concentration in saliva Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: The enzyme-linked immunosorbent assay (ELISA) will be used to quantify amylase concentration in saliva. The normal range of amylase concentration in saliva is 10-150 U/mL.
Measure: Saliva composition analysis: Change in amylase concentration in saliva Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: ELISA will be used to quantify mucin concentration in saliva.The normal range of mucin concentration in saliva is 1,000-3,000 ug/mL.
Measure: Saliva composition analysis: Change in mucin concentration in saliva Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: The University of Michigan Xerostomia Related Quality of Life (XeQOL) scale is a validated patient-reported assessment 15 item scale with 4 domains: physical functioning, pain/discomfort, personal/psychologic functioning, and social functioning. Participants will answer the questions on a scale of 1-5 (not a all, a little, somewhat, quite a bit, very much) for every item. Higher scores represent greater degree of symptoms.
Measure: Change in The University of Michigan Xerostomia Related Quality of Life (XeQOL) score Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: The MDADI is a 20-item questionnaire designed for evaluating the impact of dysphagia on the quality of life of patients with head and neck cancer. The MDADI score ranges from 20-100 with a lower scale representing worse dysphagia.
Measure: Change in The MD Anderson Dysphagia Index (MDADI) score Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: A Visual Analogue Scale questionnaire for subjective assessment of salivary dysfunction. The VAS xerostomia questionnaire is an 8-item questionnaire that provides a validated measure of the perception of dry mouth. Participants will be asked to mark their responses to each item by placing a vertical line on the 100-mm horizontal scale. The VAS ranges from 8-80 with a lower scale representing less dysphagia/symptoms
Measure: Change in Visual Analogue Scale (VAS) xerostomia score Time: at baseline, Day 30 ± 10 days, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohortDescription: Salivary gland size measured by ultrasound imaging
Measure: Change in salivary gland size Time: at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose escalation cohorts; at baseline, Day 90 ± 14 days , Day 180 ± 21 days, Day 365 ± 21 days for dose expansion cohort