Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02050503
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease
Breakthrough Pain Mucositis Radiotherapy Chemotherapy Head and Neck Cancer

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ability of Intranasal Transmucosal Fentanyl Pectin Nasal Spray to Prevent Breakthrough Pain Episodes in Patients With Radiation-induced Oropharyngeal Mucositis
Study Start Date : December 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050503


Locations
Layout table for location information
Spain
Alejandro de la Torre. Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28220
Sponsors and Collaborators
Grupo de Investigación Clínica en Oncología Radioterapia
Investigators
Layout table for investigator information
Principal Investigator: Alejandro De la Torre, MD GICOR & Hospital Puerta de Hierro

Layout table for additonal information
Responsible Party: Grupo de Investigación Clínica en Oncología Radioterapia
ClinicalTrials.gov Identifier: NCT02050503     History of Changes
Other Study ID Numbers: CP073
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Grupo de Investigación Clínica en Oncología Radioterapia:
Mucositis
Breakthrough pain
Head Nad neck cancer
Intranasal transmucosal fentanyl in pectin

Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Mucositis
Breakthrough Pain
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics