Head & Neck CancerPhase 3BEAM-PainNCT07672236
A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.
A Phase 3 study testing BupiZenge 25 mg and Lidocaine viscous 2% in people with Head & Neck Cancer and Oral Mucositis, run by OncoZenge AB at 11 sites in 4 countries.
Trial summary
Most patients who receive radiation therapy for head and neck cancer develop painful sores in the mouth called oral mucositis. For many of them, these sores are severe and result in debilitating pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head & Neck Cancer, Oral Mucositis
- What is being tested?
- BupiZenge 25 mg and Lidocaine viscous 2%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 7 Jul 2026to 31 Jan 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must provide signed written informed consent prior to trial participation and must be willing and able to comply with all requirements and restrictions of the trial.
- Male or female aged ≥ 18 on the day of consent and ≤ 80 on the first day of dosing.
- Pathologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx.
- About to start IMRT with curative intent with daily fractions of 2.0 Gy to 2.2 Gy to a cumulative intended dose of at least 60 Gy and a maximum of 72 Gy. Proton therapy given at equivalent biological doses is allowed.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Female participants of childbearing potential (WOCBP) must agree to use a highly effective contraceptive measure or practice total sexual abstinence from the time of giving informed consent until at least 24 hours after last dose of IMP.
Who cannot join
- Participation in another investigational interventional clinical trial within 3 months prior to first dosing, or for a longer period if required by local regulations, or within 5 half-lives of the investigational agent taken (whichever is longer). An exception is studies where patients are randomized to different radiotherapy settings, e.g. participation in DAHANCA 35 is allowed.
- Previous radiation therapy to the head and/or neck area.
- Pre-existing OM, active herpes simplex virus (HSV) infection, or untreated or uncontrolled oral candidiasis.
- Receiving high-dose (> 15 mg per day prednisolone), corticosteroids (for any indication).
- Known allergy or intolerance to bupivacaine, lidocaine, or any of the excipients in the products.
- Significant cardiac disease such as AV block II-III or requiring treatment with antiarrhythmic drugs in class III (e.g., amiodarone).
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- Inability to eat or drink, or dependence on an enteral feeding tube (percutaneous endoscopic gastrostomy [PEG] or nasogastric tube) for any reason.
- Moderate/severe liver or kidney disease defined as:
- AST/ALT > 3 × upper limit of normal (ULN) or bilirubin > 1.5 × ULN (unless related to Gilbert's syndrome)
- glomerular filtration rate (GFR) < 30 mL/min/1.73 m2
- Known diagnosis of epilepsy.
- Known phenylketonuria (PKU).
- Pregnancy or breastfeeding.
- Any condition or circumstance-based on the investigator's assessment-that could increase risk to the participant, confound trial results, or interfere with compliance / participation (including inability or unwillingness to follow trial procedures, or any clinically significant physical or psychiatric condition).
Trial locations and contacts
11 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 4 countries
Germany5 sites, 5 recruiting
- Not yet recruiting
University Hospital Cologne (Universitätsklinikum Köln AöR)
Cologne, 50937
- Recruiting
University Hospital Frankfurt (AöR)
Frankfurt am Main, 60596
- Recruiting
Medical Center - University Of Freiburg
Freiburg im Breisgau, 79106
- Not yet recruiting
University Hospital Schleswig-Holstein (AöR)
Kiel, 24105
- Not yet recruiting
University Hospital Tübingen (AöR)
Tübingen, 72076
Denmark3 sites, 3 recruiting
- Recruiting
Rigshospitalet, Copenhagen University Hospital
Copenhagen, 2100
- Not yet recruiting
Herlev Hospital
Herlev, 2730
- Recruiting
Næstved Hospital
Næstved, 4700
Norway2 sites, 2 recruiting
- Recruiting
Helse Bergen HF
Bergen, 5021
- Recruiting
Oslo University Hospital HF
Oslo, 0379
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, SE-17164
About this study
Official title: A Randomized, Open-label, Phase III Trial to Assess the Efficacy and Safety of BupiZenge Compared to Lidocaine for Pain Associated With Oral Mucositis in Head and Neck Cancer
Most patients who receive radiation therapy for head and neck cancer develop painful sores in the mouth called oral mucositis. For many of them, these sores are severe and result in debilitating pain. The sores usually start in the third week of radiation and last aboutfive weeks, often continuing for two weeks after treatment ends. Current pain treatments, for instance lidocaine solution, only give short-lasting pain relief.
BupiZenge is a lozenge that dissolves slowly in the mouth and contains bupivacaine. Bupivacaine is a long-acting pain-relieving medicine and has been safely used for many years for both children and adults, and its safety profile is well understood. The BupiZenge lozenge is designed to give longer and more reliable pain relief for patients with mucositis in their mouth.
Read more
This study will check if BupiZenge works better to reduce pain than lidocaine, and if better pain control improves quality of life and reduces the need for strong pain medicines like opioids.
The main goal is to see how much mouth pain decreases after taking BupiZenge compared to lidocaine. This is measured by asking the patients to rate their pain score on a scale from 0 (no pain) to 10 (worst possible pain). This is done at different time-points, from before the dose until three hours after dose on the last day of radiotherapy.
The study will include 150 adults, both women and men, aged 18 to 80 years, who have head and neck cancer and are scheduled to receive radiotherapy, with or without chemotherapy. These patients will be randomly assigned to one of the treatment groups. The first is BupiZenge, which is a lozenge containing bupivacaine, which dissolves slowly in the mouth. The second is lidocaine, which is a liquid solution for use in the mouth that you gurgle or swish around in the mouth.
The study begins with a combined screening and run-in period that can last up to five weeks. During radiotherapy, patients record their mouth pain each day using a number scale from 0 (no pain) to 10 (worst possible pain). If the pain score is at least 4 (moderate pain) and they have developed mucositis in the mouth within 5 weeks, patients are randomly assigned to receive either BupiZenge or Lidocaine.
Treatment continues at least until radiotherapy is completed. If the patient has pain and mouth sores, and the treatment is working well, it may continue after radiotherapy ends, but only until the sores heal or for a maximum of six weeks in total, whichever occurs first. After treatment ends, there is a 30-day follow-up period.
Read the detailed description
Pharmacokinetic (PK) parameters of bupivacaine in plasma will be evaluated in a sub-trial including participants randomized to the BupiZenge treatment arm.
Approximately 15 participants (no more than 25), across all designated PK sites, will participate in a PK sub-trial. Blood samples will be collected before the dose and at scheduled time points up to three hours after the dose for PK evaluation. Samples will be analyzed by a central laboratory, and results will be reported to the Sponsor or Sponsor's designee during the course of the trial. Overall, the PK sub-group represents a targeted, ethical, and efficient approach to verify systemic safety parameters for BupiZenge in the intended patient population.
- Conditions
- Head & Neck Cancer, Oral Mucositis
- Being tested
- BupiZenge 25 mg, Lidocaine viscous 2%
- Medical subject headings
- Head and Neck Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupiZenge 25 mgDrug
1 lozenge as needed. Do not chew or swallow. Dosing interval: ≥ 3 h. Max dose/24 h: 8 lozenges.
Lidocaine viscous 2%Drug
10-15 mL as needed. Hold the solution in the mouth and distribute evenly, then either spit out or swallow. Dosing interval ≥ 3 h. Max dose/24 h: 120 mL.
| Study group | Role | What they receive |
|---|---|---|
| BupiZenge | Experimental | Bupivacaine hydrochloride, 25 mg lozenge Receives: Drug: BupiZenge 25 mg |
| Lidocaine | Active comparator | Lidocaine hydrochloride oral topical solution, 20 mg/mL Receives: Drug: Lidocaine viscous 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pain reduction in oral cavity pain over 3 hours after taking study treatment on the last day of radiotherapy
Oral pain will be measured using a 0-10 numerical rating scale (0 = no pain, 10 = worst possible pain). Participants will rate their pain before taking the study treatment and at several time points after dosing. These measurements will be combined to assess how pain changes over time after treatment and to compare BupiZenge with lidocaine.
Measured: From before to 3 hours after dose, on the last day of radiotherapy
Secondary outcomes (26)
Total pain reduction in oral cavity pain over 3 hours after taking study treatment
Oral pain will be measured using a 0-10 numerical rating scale (0 = no pain, 10 = worst possible pain). Participants will rate their pain before taking the study treatment and at several time points after dosing. These measurements will be combined to assess how pain changes over time after treatment and to compare BupiZenge with lidocaine.
Measured: From before dose to 3 hours after dose, on Day 1 and during Weeks 1 to 3
Proportion of patients with meaningful pain reduction over 3 hours after taking study treatment
Oral pain will be measured using a 0-10 numerical rating scale (0 = no pain, 10 = worst possible pain). Patients who achieve at least a 30% reduction in their overall pain will be considered responders. Pain scores will be collected before dosing and at several time points after dosing, and combined to assess the overall change in pain over time. The proportion of responders will be compared between BupiZenge and lidocaine.
Measured: From before dose to 3 hours after dose, on the last day of radiotherapy and during Weeks 1 to 3
Change in oral cavity pain 15 minutes after taking study treatment
Oral pain will be measured using a 0-10 numerical rating scale (0 = no pain, 10 = worst possible pain). Weekly pain changes will be compared between BupiZenge and lidocaine.
Measured: From before dose to 15 minutes after dose during the week before end of radiotherapy and during Weeks 1 to 3 after radiotherapy
Change in oral cavity pain 60 minutes after taking study treatment
Oral pain will be measured using a 0-10 numerical rating scale (0 = no pain, 10 = worst possible pain). Weekly pain changes will be compared between BupiZenge and lidocaine.
Measured: From before dose to 60 minutes after dose during the week before end of radiotherapy and during Weeks 1 to 3 after radiotherapy
Change in oral cavity pain from Day 1 before dose to later pre-dose assessments
Oral pain will be measured using a 0-10 numerical rating scale. Weekly changes in pain before dose will be compared between BupiZenge and lidocaine.
Measured: From before dose (Day 1) to before dose during the week before end of radiotherapy and during Weeks 1 to 3 after radiotherapy
Safety as measured frequency and severity of adverse events
Adverse events and serious adverse events will be collected and graded using CTCAE v6.
Measured: From signature of informed consent up to 30 days after treatment discontinuation
Change from baseline in hematology laboratory parameters.
Hematology laboratory parameters (hemoglobin, hematocrit, red blood cell count, white blood cell count with differential count and platelet count) will be summarized by visit using descriptive statistics, including changes from baseline. The frequency of values below, within, or above the reference range will be summarized by visit.
Measured: From informed consent to 30 days after treatment discontinuation.
Change from baseline in chemistry laboratory parameters.
Chemistry laboratory parameters (CRP, Albumin, ALT, AST, ALP, Bilirubin (total and conjugated), Calcium, Potassium, Sodium, Creatinine, hCG (if applicable)) will be summarized by visit using descriptive statistics, including changes from baseline. The frequency of values below, within, or above the reference range will be summarized by visit.
Measured: From informed consent to 30 days after treatment discontinuation.
Changes from baseline in body weight
Body weight will be summarized by visit using descriptive statistics, including changes from baseline. Changes in weight will be expressed as both absolute (kg) and relative (%) changes.
Measured: From signature of informed consent up to 30 days after treatment discontinuation
Changes from baseline in blood pressure.
Blood pressure will be summarized by visit using descriptive statistics, including changes from baseline.
Measured: From signature of informed consent up to 30 days after treatment discontinuation
Changes from baseline in heart rate.
Heart rate will be summarized by visit using descriptive statistics, including changes from baseline.
Measured: From signature of informed consent up to 30 days after treatment discontinuation
Changes from baseline in body temperature .
Body temperature will be summarized by visit using descriptive statistics, including changes from baseline.
Measured: From signature of informed consent up to 30 days after treatment discontinuation
Changes from baseline in respiratory rate.
Respiratory rate will be summarized by visit using descriptive statistics, including changes from baseline.
Measured: From signature of informed consent up to 30 days after treatment discontinuation
Tolerability as measured by dose modifications due to adverse events
The number of participants who require dose modifications of study treatment due to adverse events will be recorded.
Measured: From signature of informed consent up to 30 days after treatment discontinuation
Adverse Events related to local tolerability in the oral cavity, as assessed by CTCAE v6.0, will be summarized.
Local tolerability in the oral cavity will be assessed and the result will be summarized by visit using descriptive statistics. The investigator will inspect the oral mucosa or tongue where the lozenge was placed to assess for any visible irritation or other local reaction. Any observed irritation will be documented and reported as an AE.
Measured: From Week 2 up to Week 5.
Oral intake of opioids during the treatment period with concomitant BupiZenge/lidocaine treatment and radiotherapy comparing BupiZenge with lidocaine.
Use of opioid pain medication will be recorded and converted to oral morphine milligram equivalents (MME) per day. Opioid use will be compared between BupiZenge and lidocaine.
Measured: From randomization up to Week 5.
Time (days) to start of opioid medication during radiotherapy comparing BupiZenge with lidocaine
The number of days from randomization until the participant first starts opioid pain medication will be recorded and compared between BupiZenge and lidocaine.
Measured: From randomization up to Week 5.
Change in Modified Oral Mucositis Daily Questionnaire (mOMDQ) Total Score
Participants will complete the mOMDQ. Changes in the total score will be compared between BupiZenge and lidocaine.
Measured: From randomization up to Week 5.
Quality-of-life measured as change from baseline using RAND SF-36 questionnaire
Participants will complete the Quality-of-life questionnaire RAND SF-36. The Physical Component Summary (PCS) score will be calculated according to the RAND SF-36 scoring algorithm. Change from baseline in PCS score will be summarized using descriptive statistics.
Measured: From randomization up to Week 5.
Progression of oral mucositis from WHO Grade 2 to Grade 3 or higher
The proportion of participants with worsening of oral mucositis, from WHO Grade 2 to Grade 3 or higher, during radiotherapy will be assessed and compared between BupiZenge and lidocaine.
Measured: From randomization up to Week 5.
Maximum Plasma Concentration [Cmax] of bupivaccaine in plasma.
Blood samples will be collected from approximately 15 of the participants receiving BupiZenge treatment.
Measured: Before the dose up to three hours after the dose. Two occasions per participant during the six-week treatment period
Maximum Plasma Concentration [Cmax] of bupivaccaine in plasma.
Blood samples will be collected from approximately 15 of the participants receiving BupiZenge treatment. Plasma concentrations of bupivacaine will be summarized descriptively at each time-point and visit they are assessed.
Measured: Before the dose up to three hours after the dose. Two occasions per participant during the six-week treatment period
Time to maximum Plasma Concentration [Tmax] of bupivaccaine in plasma.
Blood samples will be collected from approximately 15 of the participants receiving BupiZenge treatment. Plasma concentrations of bupivacaine will be summarized descriptively at each time-point and visit they are assessed. Tmax will be summarized using median and range.
Measured: Before the dose up to three hours after the dose. Two occasions per participant during the six-week treatment period
Area under the plasma concentration-time curve from time zero to 3 hours after dose (AUC0-3h)
Blood samples will be collected from approximately 15 of the participants receiving BupiZenge treatment. AUC 0-3h will be summarized descriptively at each time-point and visit they are assessed.
Measured: Before the dose up to three hours after the dose. Two occasions per participant during the six-week treatment period
Health Resource Utilization Questionnaire (HRUQ) Total Score at 30 days after treatment
Participants will complete the HRUQ. The questionnaire is structure for collecting healthcare utilization data in clinical research and health-economic evaluation. The total score will be compared between BupiZenge and lidocaine.
Measured: Assessed 30 days after end of treatment
Change in Work Productivity and Activity Impairment (WPAI) Total Score from baseline to 30 days after treatment
Participants will complete the WPAI questionnaire. Change from baseline in total score will be summarized using descriptive statistics.
Measured: From screening to 30 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start7 Jul 2026
- Primary completion23 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OncoZenge AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Link Medical Research AB
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer (CMO), Study director, OncoZenge AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672236
- Sponsor's protocol ID
- BZ003
- Other IDs
- 2025-524386-24-00, 2025
- Acronym
- BEAM-Pain
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to company policy and to protect participant privacy and confidential information.