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

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What is this study about?

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.

Who Can Join the Study?

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 Study?

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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Næstved Hospital	Næstved	Denmark
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Karolinska University Hospital	Solna	Sweden
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Rigshospitalet	Copenhagen	Denmark
Ulalkwxgtb Hhogwcrh Cdzpoaa	Cologne	Germany
Hyhrfq Hwsbpsix	Herlev	Denmark
Hootm Bjiotq Hx	Bergen	Norway
Alcbhc Uwgxrtzhfj Hiwbmkrt	Aarhus	Denmark
Gxdhwb Uxighqxnib Fiilyexqq	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	19.05.2026
Germany	Not yet recruiting	19.05.2026
Norway	Not yet recruiting	19.05.2026
Sweden	Not yet recruiting	19.05.2026

Trial locations

Investigated drugs:

Lidocaine Hydrochloride

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.

Investigated diseases:

Head and neck cancer

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 ID:

2025-524386-24-00

Protocol code:

BZ003

Trial Phase:

Therapeutic confirmatory (Phase III)

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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.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?