Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis
Information source: Grupo de Investigación Clínica en Oncología Radioterapia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breakthrough Pain; Mucositis; Radiotherapy; Chemotherapy; Head and Neck Cancer
Phase: N/A
Status: Completed
Sponsored by: Grupo de Investigación Clínica en Oncología Radioterapia Official(s) and/or principal investigator(s): Alejandro De la Torre, MD, Principal Investigator, Affiliation: GICOR & Hospital Puerta de Hierro
Summary
An open-label, non-randomized study to assess the titration, safety and efficacy of
intranasal fentanyl pectin nasal spray for the treatment of secondary breakthrough pain
secondary to radiation-induced mucositis in patients with confirmed tolerance of opioid
therapy for chronic pain.
Study objectives include assessment of breakthrough pain episodes related with food intake
in patients with mucositis secondary to radiotherapy or radio-chemotherapy for head and neck
tumors
Clinical Details
Official title: Ability of Intranasal Transmucosal Fentanyl Pectin Nasal Spray to Prevent Breakthrough Pain Episodes in Patients With Radiation-induced Oropharyngeal Mucositis
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Pain Intensity Difference
Secondary outcome: number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication
Detailed description:
An open, non-randomized study design was used to assess the titration, safety and efficacy
of intranasal fentanyl in pectin for the treatment of secondary breakthrough pain in
patients with confirmed tolerance of opioid therapy for chronic pain secondary to
radiation-induced mucositis. The study plans to include 30 evaluable patients from multiple
centers throughout the country. The trial comprises a screening period, an open titration
period, and an open-label treatment period in which at least 12 breakthrough pain episodes
are to be treated.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
A histologically confirmed diagnosis of head and neck carcinoma Treatment in the form of
radiotherapy or radio-chemotherapy Breakthrough pain related to swallowing (one to four
daily episodes) Treatment with controlled release opioids at the time of inclusion: at
least 60 mg of morphine sulfate daily, at least 25 microg of transdermal fentanyl per
hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily
Exclusion Criteria:
- Patients without controlled release opioid treatment.
Locations and Contacts
Alejandro de la Torre. Hospital Puerta de Hierro, Majadahonda, Madrid 28220, Spain
Additional Information
Starting date: December 2012
Last updated: March 16, 2015
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