Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis (CP073)

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

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

Study Overview

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 Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Majadahonda, Madrid, Spain, 28220
        • Alejandro de la Torre. Hospital Puerta de Hierro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adults of either sex and over 18 and under 75 years of age, receiving continued treatment with long half-life or controlled release opioids, experiencing breakthrough pain secondary to mucositis in the context of radiotherapy or radio-chemotherapy for head and neck tumors.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
intranasal transmucosal fentanyl pectin
intranasal transmucosal fentanyl in pectin (100, 200, 400 or 800 microg) intranasal route titration phase 7 days treatment phase until completing treatment of 12 consecutive episodes of breakthrough pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Difference
Time Frame: 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
30 minutes after PecFent administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication
Time Frame: 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).

12 episodes of breakthrough pain presenting within a maximum of 7 days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of intranasal transmucosal fentanyl
Time Frame: 7 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alejandro De la Torre, MD, GICOR & Hospital Puerta de Hierro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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