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A study to compare the effectiveness of bupivacaine hydrochloride monohydrate and lidocaine hydrochloride for treating mouth sores in patients with head and neck cancer.

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the effect of BupiZenge on pain in the mouth. The research focuses on individuals with Head and Neck Cancer who are experiencing Oral Mucositis, which is a painful swelling and inflammation of the mucous membranes inside the mouth. During the study, participants will receive either BupiZenge, which is a lozenge, or Lidocaine, which is an oral solution used for comparison.

Participants will be assigned to receive one of the two treatments through the mouth. The study involves monitoring the intensity of mouth pain during and after the use of these medications. This process will take place during radiotherapy, which is a common treatment for cancer that uses radiation to target cells, and for several weeks following the completion of that treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    The assignment to either bupizenge or lidocaine is determined at the start of the study.

    If assigned to bupizenge, a 200 mg lozenge is used for oromucosal use, which means it is placed in the mouth.

    If assigned to lidocaine, a 120 ml oral solution is used for oromucosal use, which means it is used in the mouth.

    The medication is used to manage pain caused by oral mucositis, which is an inflammation and soreness of the mucous membranes inside the mouth.

  2. Step 2

    Pain monitoring and assessment

    Pain intensity is measured using a numerical rating scale (nrs), which is a tool to rate how much pain is felt.

    Pain levels are recorded at the clinic on day 1, at the last day of radiotherapy, and at each week from week 1 to week 3 of the treatment.

    At these times, pain intensity is assessed before taking the dose and then at 3 hours after taking the dose.

    During the week before the end of radiotherapy and during the three weeks following radiotherapy, pain levels are also recorded at home at 15 minutes and 60 minutes after taking the dose.

  3. Step 3

    Safety and health monitoring

    Regular monitoring of adverse events, which are unwanted or side effects, is conducted to check for frequency and severity.

    Health indicators including body weight, vital signs, and laboratory values are tracked for changes.

    The local tolerability, or how well the mouth accepts the medication, is checked through visual inspection by a medical professional.

    The use of opioids, which are strong pain relief medications, is recorded to track how much is needed during the treatment period.

  4. Step 4

    Follow-up evaluations

    Additional assessments regarding the usability and work productivity are performed 30 days after the treatment is completed.

Who can join the trial?

6 criteria

  • You must provide signed written informed consent, which means you agree to take part in the study by signing a document after being fully informed about it, and you must be willing to follow all the study rules.
  • You must be male or female and at least 18 years old on the day you sign the agreement, and no older than 80 years old on the first day you receive the study medication.
  • You must have a confirmed diagnosis of squamous cell carcinoma, which is a type of cancer that starts in the thin, flat cells lining the mouth, throat, or nasal area.
  • You must be about to start IMRT, a type of specialized radiation therapy used to treat cancer, with a specific planned amount of radiation.
  • You must have an ECOG Performance Status of 0 to 2, which is a scale used by doctors to measure how well you can perform daily activities and your overall physical health while living with cancer.
  • Female participants who are able to become pregnant must agree to use an effective form of contraception (methods used to prevent pregnancy, such as birth control) or avoid pregnancy entirely from the time you sign the agreement until 24 hours after your last dose of the study medication.

Who cannot join the trial?

12 criteria

  • You have participated in another clinical trial (a research study testing new treatments) within the last 3 months, or for a longer period depending on local laws or how long the previous medicine stays in your body.
  • You have phenylketonuria (PKU), which is a rare condition where the body cannot break down a specific amino acid found in most proteins.
  • You are pregnant or currently breastfeeding.
  • You have any health issue that, in the doctor's opinion, makes the study too risky for you, might make the results inaccurate, or might prevent you from following the study rules.
  • You have previously received radiation therapy (a treatment using high-energy rays to kill cancer cells) in the head or neck area.
  • You already have oral mucositis (sores or inflammation in the mouth), an active herpes simplex virus (a common virus that causes cold sores), or an untreated oral candidiasis (a yeast infection in the mouth).
  • You are taking high doses of corticosteroids, which are a type of steroid medicine used to reduce swelling or inflammation.
  • You have a known allergy or sensitivity to bupivacaine, lidocaine, or any of the other ingredients used to make the study medicine.
  • You have significant cardiac disease (heart problems), such as AV block (a problem with the electrical signals that control your heartbeat) or if you need to take antiarrhythmic drugs (medicines used to treat irregular heartbeats).
  • You are unable to eat or drink on your own, or you rely on a feeding tube (a tube placed in the stomach or nose to provide nutrition) to eat.
  • You have moderate to severe liver or kidney disease, which is measured by specific levels in your blood tests like AST, ALT, bilirubin, or your glomerular filtration rate (GFR) (a measure of how well your kidneys filter your blood).
  • You have a known diagnosis of epilepsy (a condition that causes repeated seizures).
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Investigated drugs

  • BupiZenge

    is a lozenge used to help relieve pain in the mouth. It is being tested to see how well it works for people experiencing mouth sores and pain caused by cancer treatments.

  • Lidocaine

    is an oral liquid used to numb the mouth. In this study, it is being used as a comparison to see how effective it is at reducing pain compared to the new treatment.

What is already known about the treatment

  • BupiZenge

    This medication is a lozenge that is dissolved in the mouth to provide local relief. It is a well-known substance used in medicine to numb specific areas, particularly for managing pain caused by sores in the mouth. It works by blocking the electrical signals that send pain messages from the mouth to the brain. This drug belongs to a group called local anesthetics.

  • Lidocaine

    This is an oral liquid solution that is applied directly to the inside of the mouth. It is a widely used medication in medical practice to temporarily stop feeling in a specific area. It works at a molecular level by stopping nerve cells from sending pain signals to the rest of the body. This substance is classified as a local anesthetic.

Investigated diseases

  • Head and neck cancer

    This condition involves the uncontrolled growth of abnormal cells in the tissues of the head and neck region. These growths can start in various areas, including the mouth, throat, or salivary glands. As the disease progresses, the cancerous cells may multiply and spread to nearby tissues or lymph nodes. The development of these cells often disrupts the normal function of the affected structures.

  • Oral mucositis

    This condition is characterized by the inflammation and ulceration of the mucous membranes lining the mouth. It often occurs as a side effect of certain medical treatments, such as radiation therapy. The process typically begins with redness and swelling of the oral tissues. It can progress to the formation of painful sores or ulcers throughout the mouth.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524386-24-00Protocol codeBZ003Estimated enrolment150 patients

sourced from the EU Clinical Trials Register and site verification

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