دورية أكاديمية
Efficacy of ketamine mouthwash in the management of oral and pharyngeal toxicity associated with head and neck chemoradiotherapy: protocol for a phase II, Simon's two-stage trial.
| العنوان: | Efficacy of ketamine mouthwash in the management of oral and pharyngeal toxicity associated with head and neck chemoradiotherapy: protocol for a phase II, Simon's two-stage trial. |
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| المؤلفون: | Koffler D; Department of Radiation Medicine, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Lake Success, New York, USA., Eckstein J; Department of Radiation Medicine, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Lake Success, New York, USA., Herman J; Department of Radiation Medicine, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Lake Success, New York, USA., Martins-Welch D; Department of Palliative Medicine, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Lake Success, New York, USA., Seetharamu N; Department of Medical Oncology, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Lake Success, New York, USA., Ghaly M; Department of Radiation Medicine, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Lake Success, New York, USA., Kohn N; Division of Biostatistics, Feinstein Institute for Medical Research, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Manhasset, New York, USA., Potters L; Department of Radiation Medicine, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Lake Success, New York, USA., Frank D; Department of Otolaryngology, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Lake Success, New York, USA., Sullivan K; Department of Medical Oncology, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Lake Success, New York, USA., Parashar B; Department of Radiation Medicine, Donald and Barbara Zucker SOM at Hofstra/Northwell and Northwell Health Cancer Institute, Lake Success, New York, USA bparashar@northwell.edu. |
| المصدر: | BMJ open [BMJ Open] 2023 Apr 11; Vol. 13 (4), pp. e064809. Date of Electronic Publication: 2023 Apr 11. |
| نوع المنشور: | Clinical Trial Protocol; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| مواضيع طبية MeSH: | Ketamine*/therapeutic use , Head and Neck Neoplasms*/drug therapy, United States ; Humans ; Analgesics, Opioid/therapeutic use ; Mouthwashes/therapeutic use ; Pain/drug therapy ; Chemoradiotherapy/methods ; Clinical Trials, Phase II as Topic |
| مستخلص: | Introduction: Curative intent treatment of head and neck cancer (HNC) is frequently radiation therapy over 7 weeks with concurrent chemotherapy. This regimen is effective but carries a burden of toxicity leading to severe pain and treatment breaks portending inferior outcomes. Conventional palliation methods include opioids, anticonvulsants and local anaesthetics. Breakthrough toxicities are nevertheless ubiquitous and present an urgent unmet need. Ketamine is an inexpensive drug with mechanisms of analgesia outside the opioid pathway including N-methyl-D-aspartate (NMDA) receptor antagonism and a pharmacologically unique property of opioid desensitisation. Systemic ketamine is validated in randomised controlled trials for efficacy in reducing pain and/or opioid burden in the oncologic setting. Literature supports peripherally administered ketamine for pain control without systemic toxicity. These data support our rationale of using ketamine mouthwash to decrease acute toxicity of curative treatment of HNC, the efficacy of which is our aim to elucidate. Methods and Analysis: This is a phase II, Simon's two-stage trial. Patients have pathologically confirmed HNC and an intended regimen of 70 Gy of radiation with concurrent cisplatin. The protocol is initiated on diagnosis of grade 3 mucositis and consists of 2 weeks of 4 times daily (QID) ketamine mouthwash use. The primary endpoint is pain response defined as a combination of pain score and opioid use. 23 subjects will be enrolled in stage 1. If statistical criteria are met, 33 subjects will be enrolled in stage 2. Secondary endpoints include daily pain, daily opioid use, dysphagia at baseline and completion, nightly sleep quality, feeding tube placement and any unscheduled treatment breaks. Ethics and Dissemination: All trial data will be stored in an Institutional Review Board (IRB) approved database. The protocol is registered under Northwell IRB registration number #22-0292 and U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) approval has been granted under IND number 161609. Results are intended to be published in an open-source journal and further data, statistics and source documents are available on request. Trial Registration Number: NCT05331131. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
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| فهرسة مساهمة: | Keywords: Adult oncology; Cancer pain; Head & neck tumours; Pain management; Radiation oncology; Toxicity |
| سلسلة جزيئية: | ClinicalTrials.gov NCT05331131 |
| المشرفين على المادة: | 690G0D6V8H (Ketamine) 0 (Analgesics, Opioid) 0 (Mouthwashes) |
| تواريخ الأحداث: | Date Created: 20230411 Date Completed: 20230413 Latest Revision: 20230423 |
| رمز التحديث: | 20230423 |
| مُعرف محوري في PubMed: | PMC10105995 |
| DOI: | 10.1136/bmjopen-2022-064809 |
| PMID: | 37041046 |
| قاعدة البيانات: | MEDLINE |
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