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Teymoortash, A.* ; Pfestroff, A.* ; Wittig, A.* ; Franke, N.* ; Hoch, S.* ; Harnisch, S.* ; Schade-Brittinger, C.* ; Hoeffken, H.* ; Engenhart-Cabillic, R.* ; Brugger, M. ; Strauch, K.

Safety and efficacy of botulinum toxin to preserve gland function after radiotherapy in patients with head and neck cancer: A prospective, randomized, placebo-controlled, double-blinded phase I clinical trial.

PLoS ONE 11:e0151316 (2016)

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This prospective, randomized, placebo-controlled, double-blinded phase I clinical trial investigates safety and efficacy of botulinum toxin (BoNT) to preserve gland function after radiotherapy in patients with head and neck cancer. Twelve patients with advanced head and neck cancer were injected with BoNT into the submandibular glands prior to primary radiochemotherapy. Six patients received BoNT/A and 6 patients BoNT/A and B, half of each subgroup into their left and the other half into their right gland. As an internal control, sodium chloride was injected into the respective contralateral gland (placebo). For the evaluation of the salivary gland function, technetium pertechnetate salivary gland scintigraphy was performed before and after the end of radiotherapy. BoNT/A and B were well tolerated. Analysis of the scintigraphic data revealed no statistically significant difference between BoNT and placebo regarding the scintigraphic uptake difference (pBoNT/A = 0.84 and pBoNT/A-B = 0.56 for BoNT/A vs. placebo and BoNT/A-B vs. placebo, respectively). We also found no significant difference in treatment between BoNT and placebo in terms of salivary excretion fraction (pBoNT/A = 0.44; pBoNT/A-B = 0.44). This study demonstrates that BoNT can be safely combined with radiochemotherapy. Dosing and timing of BoNT injection should be further investigated for efficacy analysis. TRIAL REGISTRATION: German Registry for Clinical Trails DRKS00004595.

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Publication type Article: Journal article

Document type Scientific Article

Corresponding Author

Keywords Radiation-induced Xerostomia; Salivary Hypofunction; Parotid-gland; Acinar-cells; Management; Receptor; Flow

ISSN (print) / ISBN 1932-6203

Journal PLoS ONE

Quellenangaben Volume: 11, Issue: 3, Article Number: e0151316

Publisher Public Library of Science (PLoS)

Publishing Place Lawrence, Kan.

Non-patent literature Publications

Reviewing status Peer reviewed

Institute(s) Institute of Genetic Epidemiology (IGE)