MucositisPhase 2NCT02252926
Local Anesthetic Treatment of Oral Pain in Patients With Mucositis
A Phase 2 study testing Bupivacaine and Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin) in people with Mucositis, run by Hvidovre University Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mucositis
- What is being tested?
- Bupivacaine and Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- known hypersensitivity towards bupivacaine or other local anesthetics of the amide type
- pregnancy
- women breastfeeding a child
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Oncology, Rigshospitalet
Copenhagen, 2100
Department of Oncology, Herlev Hospital, Denmark
Herlev, 2730
About this study
Official title: Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis
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
- Being tested
- Bupivacaine, Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)
- Keywords
- Anesthetics, Local, Bupivacaine, Lozenge, Administration, Topical
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
25 mg bupivacaine lozenge
Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)Drug
Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (3)
Duration of the effect of the lozenge
Mean value of the pain score (VAS) measured 120 minuts after the administration of a lozenge for the patients receiving the lozenges compared with the mean value of the pain score (VAS) measured every second hour for the patients receiving the standard treatment.
Measured: 7 days
Effect of the bupivacaine lozenge
The difference in pain score (VAS) between the first score in the morning before the first lozenge of the day and the score 60 minuts after the administration of the lozenge. Pain is scored both in the oral cavity and the pharynx.
Measured: 7 days
Safety: Peak plasma concentrations of bupivacaine
The first ten patients receiving the bupivacaine lozenge will on day seven (the last day of their treatment period) get blood samples drawn before a lozenge is administrated and at time 30 min, 60 min. and 90 min. after the administration.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MucositisStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Moberg Pharma, Sweden
- Responsible party
- Principal investigator, Claus Andrup Kristensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Claus A Kristensen, MD, PhD, Principal investigator, Copenhagen University Hospital, RigshospitaletJens Bentzen, MD, Principal investigator, Department of Oncology Herlev Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252926
- Sponsor's protocol ID
- P2HNC01
- Status last verified
- Aug 2016
- First submitted
- 10 Sep 2014
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29392234
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis
- ClinicalTrials.gov ID
- NCT02252926
- Acronym / sponsor ID
- P2HNC01
- Conditions
- Mucositis
- Keywords
- Anesthetics, Local, Bupivacaine, Lozenge, Administration, Topical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Moberg Pharma, Sweden
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine lozenge | Active comparator | Drug: BupivacaineThe 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). |
| Standard treatment | Other | Drug: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- known hypersensitivity towards bupivacaine or other local anesthetics of the amide type
- pregnancy
- women breastfeeding a child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine25 mg bupivacaine lozenge | Drug | Bupivacaine lozenge |
| Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin | Drug | Standard treatment |
Primary outcome
Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)
Time frame: 7 days
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.
3 secondary outcomes
Duration of the effect of the lozenge
Time frame: 7 days
Effect of the bupivacaine lozenge
Time frame: 7 days
Safety: Peak plasma concentrations of bupivacaine
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Derived from this study: PubMed 29392234Mogensen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claus A Kristensen, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
Jens Bentzen, MD principal investigator
Department of Oncology Herlev Hospital, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacaine and Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin) in people with Mucositis, run by Hvidovre University Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02252926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.