A Mouthwash Medicine for the Reduction or Prevention of Mouth Ulceration Caused by Radiotherapy f… (NCT06669390) | Clinical Trial Compass
CompletedPhase 1
A Mouthwash Medicine for the Reduction or Prevention of Mouth Ulceration Caused by Radiotherapy for Head and Neck Cancer
United Kingdom15 participantsStarted 2023-05-22
Plain-language summary
This study is looking at a new medication called NG11-2 to see if it can reduce a side effect called severe Radiation-induced Oral Mucositis (RIOM) that can happen to people getting radiation treatment for head and neck cancer. Severe RIOM can make patients very sick and make it hard for them to finish their cancer treatment. Right now, there are no approved drugs that can prevent or treat severe RIOM. This study will test different doses of NG11-2 to find the best one, and then more patients will take that dose to see if it works. This study is being done at multiple hospitals in the UK.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female head and neck cancer patients scheduled for radiotherapy, aged 18 or over on day of signing informed consent;
✓. Histologically confirmed head and neck cancer with or without previous resective surgery, having not been previously treated with radiation therapy
✓. Scheduled to receive a mean radiation dose of no less than 30 Gy on either (a) Extended Oral Cavity, or (b) Buccal Mucosa, or (c) Lips, according to CT-based delineation of Organ-At-Risk (OAR) Guideline, with or without concurrent chemotherapy (Section 13.8 for guidance);
✓. Rendered dentally fit for radiotherapy;
✓. Have a Performance Status \>60 on the Karnofsky scale
✓. No evidence of active systemic infections at the time of screening;
✓. No oral fungal infection by visual examination or swab test;
✓. Body Mass Index \>=18.5 kg/m²
Exclusion criteria
✕
What they're measuring
1
Occurence of Dose Limiting Toxicities (DLT)
Timeframe: Dose Limiting Toxicities will be evaluated throughout the study from time of patient consent until 42 days after last IMP dose
2
Occurence of Serious Adverse Events (SAE)
Timeframe: Serious Adverse Events will be evaluated throughout the study from time of patient consent until 42 days after last IMP dose
✕. Mentally or legally incapacitated, in the opinion of the PI, which could interfere with the ability of the patient to understand or adhere to the requirements of the study;
✕. Open or unhealed non-cancerous wounds or ulcers in the oral cavity;
✕. WHO Oral Mucositis grade of 2 or more
✕. Uncontrolled Hypertension, defined as blood pressure in adults \>150/100mm Hg at screening;
✕. A known clinically significant abnormal ECG, such as arrhythmia and active ischemia,within 6 months prior to treatment;
✕. Xerostomia or hyposalivation;
✕. Known allergy or intolerance to sympathomimetic drugs (e.g., pseudoephedrine, epinephrine), alcohol, or any NG11-2 excipient;