A mouthwash medicine for the reduction or prevention of mouth ulceration caused by radiotherapy for head and neck cancer
- Conditions
- Reduction of radiation-induced oral mucositis in head & neck cancer patients undergoing radiotherapy with or without concomitant chemotherapyOral Health
- Registration Number
- ISRCTN87831050
- Lead Sponsor
- VasoDynamics Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 32
1. Male or female head and neck cancer patients scheduled for radiotherapy, aged 18 or over on day of signing informed consent;
2. Histologically confirmed head and neck cancer with or without previous resective surgery, having not been previously treated with radiation therapy
3. 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);
4. Rendered dentally fit for radiotherapy;
5. Have a Performance Status >60 on the Karnofsy scale
6. No evidence of active systemic infections at the time of screening;
7. No oral fungal infection by visual examination or swab test;
8. Body Mass Index >=18.5 kg/m²
9. Normalcy of diet evaluated with the Performance Status Scale for Head and Neck cancer patients (PSSHN) >=30;
10. Ability to retain and swill liquid inside the oral cavity for at least 90 seconds;
11. Female patients of childbearing potential must have a negative urine or serum pregnancy test during the 2 week Screening period
12. Provide written informed consent for the trial.
13. Consent to utilize medically acceptable methods of contraception throughout the study period if of child-bearing potential;
14. Be able to comply with protocol procedures (such as Oral Mucositis assessment and swish/spit) and study schedule
1. Tumour of the larynx
2. 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 more
5. 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 study
11. Current participation in any other oral mucositis studies or completion/ withdrawal from any other oral mucositis studies within the last 3 months
12. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurence of Dose Limiting Toxicities (DLT) & Serious Adverse Events (SAE). Serious Adverse Events will be evaluated throughout the study from time of patient consent until 42 days after last IMP dose. Dose limiting toxicities will be evaluated from time of first dose until 42 days after last IMP dose. Additionally all available safety data (AEs, SAEs and DLTs) will be reviewed and evaluated by a Safety Committee (Sponsor CMO, Study Medical Monitor & Chief Investigator) before each dose escalation.
- Secondary Outcome Measures
Name Time Method 1. Duration of severe RIOM (WHO, RTOG and NCI-CTCAE v5 Gr 3 or above) evaluated by Oral Mucositis assessments at screening and twice weekly in each week of study treatment in weeks 1-7, and then at 7, 14, 28 and 42 days post end of Radiotherapy, in the follow-up period.<br>2. Incidence & Time to onset of severe RIOM (WHO, RTOG and NCI-CTCAE v5 Gr 3 or above)<br>3. Patient Reported Outcome Measure - Oral Mucositis (PROM-OM) evaluated at the same timepoints as the clinical Oral Mucositis assessments, namely screening and twice weekly in each week of study treatment in weeks 1-7, and then at 7, 14, 28 and 42 days post end of Radiotherapy, in the follow-up period.