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A Mouthwash Medicine for the Reduction or Prevention of Mouth Ulceration Caused by Radiotherapy for Head and Neck Cancer

NCT06669390 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-11-01

No results posted yet for this study

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.

Conditions

  • Oral Mucositis

Interventions

DRUG

NG11-2

NG11-2 dose level will vary from 0.92 mg/mL to 5.5 mg/mL during the dose escalation process. The NG11-2 is given as an oral rinse. Throughout the radiotherapy regimen, no more than 60 minutes prior to the completion of radiotherapy, on each weekday the patient will rinse their mouth with 12.5 ml of NG11-2 for between 90 \& 120 seconds duration, gargling twice for approximately three seconds each if possible during this period then expectorate the solution.

Sponsors & Collaborators

  • VasoDynamics Ltd

    lead INDUSTRY

Principal Investigators

  • Dr Mary Lei · Guy's & St Thomas' Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-22
Primary Completion
2024-08-20
Completion
2024-08-20

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06669390 on ClinicalTrials.gov