Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

NCT ID: NCT02252926

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Bupivacaine lozenge

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).

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

25 mg bupivacaine lozenge

Standard treatment

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.

Group Type: OTHER

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

Intervention Type: DRUG

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

Interventions

Bupivacaine

25 mg bupivacaine lozenge

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moberg Pharma, Sweden

UNKNOWN

Sponsor Role: collaborator

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Claus Andrup Kristensen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claus A Kristensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Rigshospitalet, Denmark

Jens Bentzen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology Herlev Hospital, Denmark

Locations

Department of Oncology, Rigshospitalet

Copenhagen, , Denmark

Department of Oncology, Herlev Hospital, Denmark

Herlev, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 29392234 (View on PubMed)

Other Identifiers

P2HNC01

Identifier Type: -

Identifier Source: org_study_id