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

Completed

• Conditions: Chemotherapy; Breakthrough Pain; Mucositis; Head and Neck Cancer; Radiotherapy

• Registration Number: NCT02050503
• Lead Sponsor: Grupo de Investigación Clínica en Oncología Radioterapia

Brief 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

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-30
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-16
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Intensity Difference	30 minutes after PecFent administration	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

Secondary Outcome Measures

Name	Time	Method
number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication	12 episodes of breakthrough pain presenting within a maximum of 7 days.	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).

Trial Locations

Locations (1)

Alejandro de la Torre. Hospital Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain