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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Mary Lei
+44 20 71884219
Mary.Lei@gstt.nhs.uk


Mr Gary Bower
+44 1438 300880
gary.bower@vasodynamics.co.uk


Dr Ningfeng Fiona LI
-
fiona.li@vasodynamics.co.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - A mouthwash medicine for the reduction or prevention of mouth ulceration caused by radiotherapy for head and neck cancer
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A mouthwash medicine for the reduction or prevention of mouth ulceration caused by radiotherapy for head and neck cancer

Not Recruiting

Open to: All Genders

Age: Adult

Aberdeen Lothian Belfast London Birmingham

Medical Conditions

Reduction of radiation-induced oral mucositis in head & neck cancer patients undergoing radiotherapy with or without concomitant chemotherapy

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 May 2023 30 Jun 2024

Daily treatment with NG11-2 will occur prior to radiotherapy for 5 days/week for up to 7 weeks. Throughout the radiotherapy regimen, no more than 60 minutes prior to the completion of radiotherapy, on each weekday the patient will be instructed to
a) rinse their mouth twice with room temperature water in the 5 minutes prior to NG11-2 treatment then
b) rinse their mouth with 12.5ml of NG11-2 for between 90 & 120 seconds duration, gargling twice for approximately three seconds each if possible during this period then
c) expectorate the solution
Treatment will continue for up to 7 weeks with a 6-week follow-up period.


Patients aged 18 years or older, with head and neck cancer.

You can take part if:



You may not be able to take part if:


1. Tumour of the larynx2. 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;3. Open or unhealed non-cancerous wounds or ulcers in the oral cavity;4. WHO Oral Mucositis grade of 2 or more5. Uncontrolled Hypertension, defined as blood pressure in adults >150/100mm Hg at screening;6. A known clinically significant abnormal ECG, such as arrhythmia and active ischemia,within 6 months prior to treatment;7. Xerostomia or hyposalivation;8. Known allergy or intolerance to sympathomimetic drugs (e.g., pseudoephedrine, epinephrine), alcohol, or any NG11-2 excipient;9. Receiving monoamine oxidase (MAO) inhibitors or antidepressants (triptyline or imipramine types); Use of MAO inhibitor in the 14 days prior to treatment, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine;10. History or current evidence of clinically significant laboratory abnormality or any disease condition that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study11. Current participation in any other oral mucositis studies or completion/ withdrawal from any other oral mucositis studies within the last 3 months12. Patient is, at the time of signing informed consent, a regular user of any illicit drugs, which would interfere with cooperation with the requirements of the trial;13. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study;14. Any other condition which, in the opinion of the Investigator, means that the patient is not a good candidate for study enrolment


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Aberdeen Royal Infirmary
    Foresterhill Road
    Aberdeen
    AB25 2ZN
  • Western General Hospital
    Crewe Road South Edinburgh
    Lothian
    EH4 2XU
  • Belfast City Hospital
    51 Lisburn Rd
    Belfast
    BT9 7AB
  • Guys Hospital
    Guys Hospital Great Maze Pond
    London
    SE1 9RT
  • Queen Elizabeth Hospital
    Queen Elizabeth Medical Centre Edgbaston
    Birmingham
    B15 2TH

Benefits:
Possibly prevention/ reduction in severe Radiation-induced Oral Mucositis during the patient's radiotherapy treatment
Risks:
The study will fit in with the usual treatment and the only additional things that patients will have to do are: give a small number of extra blood samples, have some patches put on their chest for an electrocardiogram (ECG), and fill out a short questionnaire a few times. Patients will also have to rinse their mouths with the NG11-2 solution before each radiation treatment. The study drug is made with adrenaline, which is a well-understood drug, but it may cause some mild side effects like irritation in the mouth or a temporary change in heart rate. The study team will closely monitor patients for any side effects and will stop treatment if needed.
Although the scientific rationale and earlier laboratory studies suggest that NG11-2 treatment is unlikely to have a negative impact on your tumour treatment, we cannot yet exclude the risk of a negative impact on your anticancer therapy when treated with NG11-2.

Mr Gary Bower
+44 1438 300880
gary.bower@vasodynamics.co.uk


Dr Mary Lei
+44 20 71884219
Mary.Lei@gstt.nhs.uk


Dr Ningfeng Fiona LI
-
fiona.li@vasodynamics.co.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by VasoDynamics Ltd and funded by Vasodynamics.



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Read full details for Trial ID: ISRCTN87831050

Or CPMS 54459

Last updated 04 October 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

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