Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

NCT02252926 | Completed Phase 2 DMC

• 1 other identifier: P2HNC01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and painful adverse effect caused by the radio therapy and/or chemo therapy patients with head and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the current treatment with opioids is not sufficient and can cause adverse effects. Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce the oral pain caused by mucositis compared with the current standard treatment.

Conditions

Mucositis

Keywords

Anesthetics, Local; Bupivacaine; Lozenge; Administration, Topical

Outcome Measures

Primary Outcomes (1)

• Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)

  The primary outcome measure is the mean VAS score for the patients in the bupivacaine lozenge group compared with the mean VAS score for the patients in the standard treatment group. The lozenge group measures VAS before and 60 min. after administration of a lozenge for seven days. The standard treatment group measures VAS every second hour for seven days.

  7 days

Secondary Outcomes (3)

• Duration of the effect of the lozenge

  7 days

• Effect of the bupivacaine lozenge

  7 days

• Safety: Peak plasma concentrations of bupivacaine

  90 minutes

Study Arms (2)

Bupivacaine lozenge

ACTIVE COMPARATOR

The patients can take up to eight 25 mg bupivacaine lozenges (max. every second hour in the awake hours) a day for seven days. The patients can use concomitant systemic pain treatment (e.g. morphine).

Drug: Bupivacaine

Standard treatment

OTHER

The patients will be treated with the currently used standard pain treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin). The anesthetics are being administered at the physician's discretion.

Drug: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)

Interventions

Bupivacaine DRUG

25 mg bupivacaine lozenge

Bupivacaine lozenge

Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin) DRUG

Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin

Standard treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with head/neck cancer and starting radio therapy treatment
• age between 18 and 80 years (both included)
• able to talk, read and understand Danish
• ability to give informed consent

You may not qualify if:

• known hypersensitivity towards bupivacaine or other local anesthetics of the amide type
• pregnancy
• women breastfeeding a child

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Moberg Pharma, Sweden: collaborator

Study Sites (2)

Department of Oncology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Oncology, Herlev Hospital, Denmark

Herlev, 2730, Denmark

Location

Related Publications (1)

• Mogensen S, Treldal C, Kristensen CA, Bentzen J, Lawson-Smith L, Petersen J, Andersen O. Effect of bupivacaine lozenges on oral mucositis pain: a randomized controlled multicenter phase II study. Pain Rep. 2017 Aug 23;2(5):e619. doi: 10.1097/PR9.0000000000000619. eCollection 2017 Sep.

  PMID: 29392234 DERIVED

MeSH Terms

Conditions

Mucositis

Interventions

Bupivacaine; Morphine; Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Gabapentin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Claus A Kristensen, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Jens Bentzen, MD

  Department of Oncology Herlev Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 30, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

DK (2)