Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis

Head and Neck Cancer Clinical Trial

— CP073  

Official title:

Ability of Intranasal Transmucosal Fentanyl Pectin Nasal Spray to Prevent Breakthrough Pain Episodes in Patients With Radiation-induced Oropharyngeal Mucositis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050503
• Other study ID #: CP073
• Status: Completed
• Phase: N/A
• First received: January 29, 2014
• Last updated: March 16, 2015
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Grupo de Investigación Clínica en Oncología Radioterapia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breakthrough Pain
• Chemotherapy
• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Radiotherapy

Locations

Country	Name	City	State
Spain	Alejandro de la Torre. Hospital Puerta de Hierro	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Grupo de Investigación Clínica en Oncología Radioterapia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety of intranasal transmucosal fentanyl	The appearance of adverse effects during the study Physical examination at each visit Vital signs: blood pressure, pulse Concomitant medication for breakthrough pain Reasons for patient study withdrawal (in the event of withdrawal)	7 days	Yes
Primary	Pain Intensity Difference	Pain Intensity difference: Pain Intensity will be measured 30 min after starting food intake during the screening phase and 30 min after intranasal transmucosal fentanyl in pectin administration/food intake during the treatment phase	30 minutes after PecFent administration	No
Secondary	number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication	The number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication.; Patient rating of drug efficacy measured on a scale from 0 to 10 (0 = ineffective, 10 = totally effective).; Quality of life assessed with the European Organization for Research and Treatment of Cancer quality of life questionnaire -INF025 in its validated Spanish version, administered on the screening visit and at the end of the study.; Patient rating of drug ease of use measured on a scale from 1 to 4 (1 = very complicated, 4 = very simple).	12 episodes of breakthrough pain presenting within a maximum of 7 days.	No