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NCT Number: NCT02050503

Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in 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

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Key information

Conditions

Breakthrough Pain Chemotherapy Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Mucositis Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Radiotherapy Signs and Symptoms Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alejandro de la Torre. Hospital Puerta de Hierro

Majadahonda, Madrid, 28220, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Grupo de Investigación Clínica en Oncología Radioterapia

Other

Registry information

Official study title

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

Acronym: CP073

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 30, 2014
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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