Effectiveness and safety of mesenchymal stem/stromal cell for radiation-induced hyposalivation and xerostomia in previous head and neck cancer patients (MESRIX-III): a study protocol for a single-centre, double-blinded, randomised, placebo-controlled, phase II study.

Kathrine Kronberg JakobsenAmanda-Louise Fenger CarlanderChristian GrønhøjTobias TodsenJacob MelchiorsNatasja PaaskeAnne Kathrine Østergaard MadsenJens KastrupAnnette EkblondMandana Haack-SørensenMohammad FarhadiChristian MaareJeppe FriborgCharlotte Duch LynggardChristian von Buchwald

Published in: Trials (2023)

The study is approved by the Danish Data Protection Agency (protocol number P-2020-1164), the National Ethics Committee protocol number: (Protocol number: 1802872), and the Danish Medical Agency (2018-000348-24). The protocol was registered at the ClinicalTrials.gov database (NCT04776538).

Keyphrases

phase ii study
radiation induced
randomized controlled trial
placebo controlled
open label
bone marrow
clinical trial
healthcare
study protocol
stem cells
big data
radiation therapy
drug administration
emergency department
cell therapy
electronic health record
mesenchymal stem cells
rectal cancer