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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. No oral fungal infection by visual examination or swab test;
. Body Mass Index \>=18.5 kg/m²
Exclusion criteria
. Tumour of the larynx
. 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;