title: 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.
abstract: 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.
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Philipp University, Marburg, Germany.
authors.forename: Afshin
authors.initials: A
authors.lastname: Teymoortash
authors.affiliation: Department of Nuclear Medicine, Philipp University, Marburg, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Pfestroff
authors.affiliation: Department of Radiotherapy and Radio-Oncology, Philipp University, Marburg, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Wittig
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Philipp University, Marburg, Germany.
authors.forename: Nora
authors.initials: N
authors.lastname: Franke
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Philipp University, Marburg, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Hoch
authors.affiliation: Center for Clinical Trials, Philipp University, Marburg, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Harnisch
authors.affiliation: Center for Clinical Trials, Philipp University, Marburg, Germany.
authors.forename: Carmen
authors.initials: C
authors.lastname: Schade-Brittinger
authors.affiliation: Department of Nuclear Medicine, Philipp University, Marburg, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Hoeffken
authors.affiliation: Department of Radiotherapy and Radio-Oncology, Philipp University, Marburg, Germany.
authors.forename: Rita
authors.initials: R
authors.lastname: Engenhart-Cabillic
authors.affiliation: Institute of Medical Informatics, Biometry and Epidemiology, Chair of Genetic Epidemiology, Ludwig-Maximilians-Universität, Munich, Germany.|Institute of Genetic Epidemiology, Helmholtz Zentrum München-German Research Center for Environmental Health, Neuherberg, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Brugger
authors.affiliation: Institute of Medical Informatics, Biometry and Epidemiology, Chair of Genetic Epidemiology, Ludwig-Maximilians-Universität, Munich, Germany.|Institute of Genetic Epidemiology, Helmholtz Zentrum München-German Research Center for Environmental Health, Neuherberg, Germany.|Institute of Medical Biometry and Epidemiology, Philipp University, Marburg, Germany.
authors.forename: Konstantin
authors.initials: K
authors.lastname: Strauch
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011877:Radionuclide Imaging / Q000379:methods; D011878:Radiotherapy / Q000009:adverse effects*; D012469:Salivary Glands / Q000187:drug effects* / Q000502:physiology / Q000528:radiation effects; D000077195:Squamous Cell Carcinoma of Head and Neck; D016896:Treatment Outcome
chemical_list: C096323:rimabotulinumtoxinB; D019274:Botulinum Toxins, Type A