Treatment of Post-radiation Xerostomia With Allogeneic Mesenchymal Stromal Stem Cells

Launched by INSTITUTE OF ONCOLOGY LJUBLJANA · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients who experience dry mouth (xerostomia) after receiving radiation therapy for head and neck cancer. The researchers want to see if using special cells called mesenchymal stromal stem cells, taken from umbilical cord tissue, can help improve saliva production and overall salivary gland function. The main focus of the study is to determine if this treatment is safe for patients, while also looking at how effective it might be in relieving the symptoms of dry mouth.

To be eligible for the trial, participants should be between 18 and 75 years old, have had specific types of head and neck cancer, and completed their radiation treatment at least two years ago without any signs of cancer returning. They must also be experiencing moderate to severe dry mouth and have certain levels of saliva flow. If someone decides to join, they will receive the stem cell treatment in their salivary glands and will be monitored closely for any side effects and improvements in their condition. This study is not yet recruiting participants, but it aims to help improve the quality of life for those suffering from dry mouth after cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • squamous cell carcinoma of the oropharynx, Union for International Cancer Control TNM Classification of Malignant Tumors )8th ed.) clinical stage T1-2N+ or cT3-4cN0-3 M0, treated with curative intent radiotherapy (tumor dose 66-70 Gy, bilateral neck irradiation) with or without concurrent chemotherapy
• • 2 years or more post-treatment without signs of locoregional recurrence or systemic metastasis
• • non-smoker or former smoker (quit smoking ≥2 years ago)
• • mean radiation dose \>26 Gy to each of the parotid glands and \>35 Gy to each of the submandibular glands
• • xerostomia of grade 2 or 3, assessed according to the CTCAE v5.0 scale
• • Clinically reduced salivary flow and hyposalivation (unstimulated whole saliva flow rate 0.05-0.20 ml/min)
• • age between 18-75 years
• • both sexes
• • signed "Informed Consent Form" for participation in the study
• Exclusion Criteria:
• • newly diagnosed malignancy anywhere in the body within the past two years
• • active smoker
• • use of medications with potential to cause dry mouth (e.g., tricyclic antidepressants, antipsychotics, decongestants, bronchodilators, antihypertensives like beta-blockers and diuretics, antihistamines, hypnotic sedatives, opioids, and muscle relaxants)
• • other salivary gland diseases (e.g., Sjögren's syndrome, scleroderma, sialolithiasis, etc.)
• • patients on anticoagulant therapy that cannot be discontinued during the intervention
• • pregnancy or planned pregnancy within the next two years
• • breastfeeding
• • active, uncontrolled infection or other medical (including psychiatric) conditions that, in the researchers' opinion, do not allow for the safe administration of the planned therapy and performance of the follow-up procedures
• • known substance abuse or alcoholism