Status:
WITHDRAWN
Efficacy of Ketamine Mouthwash in the Management of Oral and Pharyngeal Toxicity Associated With Head and Neck Chemoradiotherapy: A Phase 2, Simon 2-stage Trial
Lead Sponsor:
Northwell Health
Conditions:
Cancer of Head and Neck
Mucositis Oral
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Patients with head and neck cancer generally receive a standard of care of 7 weeks of daily radiation therapy given alongside an aggressive chemotherapy drug called cisplatin. While rates of cure are ...
Detailed Description
There is an unmet need for improvement in pain control among patients with cancer and undergoing anti-neoplastic therapies, with by one recent estimate 59% of patients on treatment and 33% of patients...
Eligibility Criteria
Inclusion
- Adults aged 18-70
- Pathologically proven squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, larynx, or hypopharynx, with the exception of stages I-II glottic cancer
- Prescribed a curative regimen of definitive radiotherapy to with concurrent cisplatin-based chemotherapy, administered in standard fractionated doses to 70 Gy in 35 Fx
- CTCAE v 5.0 grade 3 or greater oral cavity or pharyngeal mucositis documented to have developed subsequent to initiation of radiation therapy, defined as severe pain limiting oral intake, with at least 14 remaining days on treatment with radiation therapy
Exclusion
- Unable to render informed consent
- Prior history of radiation therapy
- Any other malignancy diagnosed or treated within 10 years prior to enrollment
- Feeding tube placement or tracheostomy prior to initiation of radiation therapy
- Deemed by attending radiation oncologist to be unlikely to adhere to the QID study intervention and daily outcomes reporting as described below
- Any of the following contraindications for ketamine use: high risk for complications due to blood pressure elevation, documented hypersensitivity to ketamine, history of illicit drug use disorder, history of psychotic disorder, or any other medical contraindication attested to by the attending radiation oncologist
- Pregnant or breastfeeding at the time of screening visit
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05331131
Start Date
September 19 2022
End Date
November 14 2025
Last Update
January 24 2024
Active Locations (1)
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1
Center for Advanced Medicine
Lake Success, New York, United States, 11042