BupiZenge vs Lidocaine for mouth pain from oral mucositis in head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, interventional study compares a bupivacaine-containing lozenge (BupiZenge) with lidocaine viscous to treat oral mucositis pain in adults with head and neck cancer undergoing curative-intent radiotherapy. The trial includes a pharmacokinetic sub-study to measure bupivacaine levels in plasma and assess systemic safety. Primary endpoints focus on pain reduction and quality of life, with exploration of opioid-sparing effects. About 15 to 25 participants are planned for the PK sub-trial across designated sites, while the overall study enrolls patients at multiple institutions. Safety monitoring and central laboratory analyses support the evaluation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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:

  1. AST/ALT \> 3 × upper limit of normal (ULN) or bilirubin \> 1.5 × ULN (unless related to Gilbert's syndrome)
  2. 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).

Where it's running

• Rigshospitalet, Copenhagen University Hospital
  Copenhagen, Denmark Recruiting
• Herlev Hospital
  Herlev, Denmark Recruiting
• Næstved Hospital
  Næstved, Denmark Recruiting
• University Hospital Frankfurt (AöR)
  Frankfurt am Main, Germany Recruiting
• Medical Center - University Of Freiburg
  Freiburg im Breisgau, Germany Recruiting
• University Hospital Schleswig-Holstein (AöR)
  Kiel, Germany Recruiting

Study contacts

• Study coordinator: Chief Executive Officer (CEO)
• Email: info@oncozenge.se
• Phone: +468311420

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Copaiba Mouthwash with Low-Level Laser Therapy to Prevent Mouth Sores After Stem Cell Transplant

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• Proton Re-irradiation for Head and Neck Cancer Recurrence

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• Intratumoral EDS01 plus toripalimab for recurrent or metastatic head and neck cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.