E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Oral pain due to oral mucositis in head and neck cancer patients which are undergoing radiation therapy |
Orale smerter som følge af oral mucositis hos hoved/halscancer patienter i stråleterapi |
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E.1.1.1 | Medical condition in easily understood language |
Oral pain due to oral inflammation in head and neck cancer patients which are undergoing radiation therapy |
Mundsmerter på grund af betændelse i munden hos hoved/hals kræft patienter i strålebehandling |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028130 |
E.1.2 | Term | Mucositis oral |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037763 |
E.1.2 | Term | Radiation mucositis |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate if bupivacaine lozenges are an effective and patient friendly pain treatment for oral pain in head and neck cancer patients with oral mucositis and thereby reduce the need for opioids as pain treatment in this patient group compared to standard pain treatment. |
Undersøge om bupivacainsugetabletter er en effektiv og patientvenlig smertebehandling mod mundsmerter for hoved/hals cancer patienter med oral mucositis. |
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E.2.2 | Secondary objectives of the trial |
Reduction of the use of opioids as additional pain treatment in the lozenge group compared to standard treatment group |
Reduktion i forbruget af opioider som yderligere smertebehandling i sugetabletgruppen sammenlignet med standardbehandlingsgruppen |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnosed with head and neck cancer and scheduled for radiation therapy
- Age between 18 and 80
- Be able to speak, read and understand danish
- Be able to give informed written consent
- Be able to use an electronic media with a touch screen, such as a smart phone or a tablet PC
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Diagnosticeret med hoved/hals cancer og have planlagt strålebehandling
- Alder mellem 18 og 80 år
- I stand til at tale, læse og forstå dansk
- Skal kunne afgive informeret skriftligt samtykke
- I stand til at et bruge elektronisk medie med touch screen, så som smartphone og tablet PC.
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E.4 | Principal exclusion criteria |
- Known allergy to bupivacaine or other local analgesia of the amid type
- Pregnancy
- Breast feeding women
- Use of opioid pain treatment before start of radiation treatment
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- Kendt allergi overfor bupivacain eller andre lokalanalgetika fra amidgruppen
- Graviditet
- Ammende kvinder
- Behov for smertebehandling med morfin før strålebehandlingen start.
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E.5 End points |
E.5.1 | Primary end point(s) |
Measurement of the oral pain on a visual analogue scale from 0-100 mm, where 0 = no pain and 100 = worst thinkable oral pain |
Patienternes orale mucositis smerter, vist ved scoring på den Visuelle Analog Skala (VAS) 0-100 mm, hvor 0 = ingen smerter og 100 = værst tænkelige mundsmerter |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The patient has to measure VAS before administration of each bupivacaine lozenge and 60 minutes after. In the control group will VAS be measured every 2 hours. |
VAS måles før administration af hver bupivacainsugetablet samt 60 minutter efter administration for sugetabletgruppen. For kontrolgruppen måles VAS hver anden time. |
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E.5.2 | Secondary end point(s) |
- Reduction of the patient’s opioid use in the lozenge group compared to the opioid use in the control group measured in mg/day
- Reduction in days on opiods in the trial period for the lozenge group compared to the control group.
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- Nedsættelse af patienternes forbrug af opioid målt i mg/dag for bupivacainsugetablet gruppen sammenlignet med opioid forbruget i kontrolgruppen
- Nedsættelse af antal dage med opioider i forsøgsperioden for bupivacainsugetablet gruppen sammenlignet med kontrolgruppen
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of trial |
Ved forsøgets afslutning |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard smertebehandlingsregime |
Standard pain treatment regime |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Sidste besøg for sidste patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |