What is BupiZenge studying for pain due to oral mucositis in head and neck cancer?

BupiZenge is being studied to see if it provides better and longer-lasting pain relief for mouth sores caused by radiation therapy in head and neck cancer patients. Researchers want to find out if BupiZenge improves quality of life and reduces the need for stronger pain medicines. This study is sponsored by OncoZenge AB.

Who may be eligible for this head and neck cancer clinical trial?

Adults aged 18 to 80 with a confirmed diagnosis of squamous cell carcinoma in specific head and neck areas may be eligible. Participants must be about to start curative radiotherapy and have a good performance status. People with allergies to study drugs or certain medical conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this head and neck cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and related expenses vary and may not be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 3

Age: 18Years - 80Years

All Genders

ID07672236

Comparing BupiZenge Lozenges to Lidocaine for Oral Mucositis Pain Relief in Adults With Head and Neck Cancer

Led by OncoZenge AB · Updated on 2026-07-13

150

Participants Needed

Research Sites

5 weeks

Total Duration

AI-Summary

What this Trial Is About

Many patients receiving radiation therapy for head and neck cancer develop painful mouth sores called oral mucositis, causing severe pain that lasts through and beyond treatment. This study evaluates whether BupiZenge, a lozenge containing the long-acting pain reliever bupivacaine, provides better pain control than lidocaine solution. The trial aims to see if improved pain management with BupiZenge enhances quality of life and reduces opioid use in adults aged 18 to 80 with head and neck cancer undergoing radiotherapy. Participants are randomly assigned to receive either BupiZenge lozenges or lidocaine oral solution. BupiZenge is taken as one lozenge that dissolves slowly in the mouth with a dosing interval of at least 3 hours, up to 8 lozenges per day. Lidocaine is used as an oral solution held in the mouth, also every 3 hours as needed, with a maximum daily dose of 120 mL. The study includes a combined screening and run-in period up to five weeks, followed by treatment during radiotherapy and for up to six weeks total if pain and sores persist after radiotherapy. Participants will record their mouth pain daily using a 0 to 10 scale, with primary measurement focusing on pain reduction over 3 hours after taking the study treatment on the last day of radiotherapy. Additional assessments include pain at other time points, opioid use, quality of life questionnaires, laboratory tests, and safety monitoring. After treatment, there is a 30-day follow-up period to evaluate lasting effects and safety outcomes.

CONDITIONS

Brief Title

A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Participant must provide signed written informed consent and be willing to follow trial requirements.
Male or female aged 18 to 80 years.
Confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx.
Scheduled to start intensity-modulated radiation therapy (IMRT) with curative intent, receiving 2.0 to 2.2 Gy daily fractions totaling at least 60 Gy.
ECOG Performance Status of 0 to 2.
Women of childbearing potential must agree to use effective contraception or abstain from sex during the study.

You will not qualify if you...

Participation in another investigational interventional trial within 3 months prior to first dose or longer as required.
Previous radiation therapy to head or neck.
Existing oral mucositis, active herpes simplex virus infection, or untreated oral candidiasis.
Use of high-dose corticosteroids (>15 mg prednisolone daily).
Known allergy or intolerance to bupivacaine, lidocaine, or product ingredients.
Significant cardiac disease such as advanced AV block or needing certain antiarrhythmic drugs.
Inability to eat or drink or dependence on feeding tubes.
Moderate to severe liver or kidney disease.
Diagnosis of epilepsy or phenylketonuria.
Pregnancy or breastfeeding.
Any condition that increases risk or interferes with study participation as judged by the investigator.

Research Team

Chief Executive Officer (CEO)

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