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Clinical Trials/EUCTR2014-002346-42-DK
EUCTR2014-002346-42-DK
Active, not recruiting
Phase 1

Clinical trial with lozenges as local pain treatment for head and neck cancer patients with oral mucostis

Copenhagen University Hospital, Hvidovre0 sitesJuly 14, 2014
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ConditionsOral pain due to oral mucositis in head and neck cancer patients which are undergoing radiation therapyMedDRA version: 17.1Level: LLTClassification code 10028130Term: Mucositis oralSystem Organ Class: 100000004856MedDRA version: 17.1Level: PTClassification code 10037763Term: Radiation mucositisSystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Oral pain due to oral mucositis in head and neck cancer patients which are undergoing radiation therapy
Sponsor
Copenhagen University Hospital, Hvidovre
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 14, 2014
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Copenhagen University Hospital, Hvidovre

Eligibility Criteria

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
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 30
  • •F.1\.3 Elderly (\>\=65 years) yes

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

Outcomes

Primary Outcomes

Not specified

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