Clinical trial NCT02050503: Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis
Official title: Ability of Intranasal Transmucosal Fentanyl Pectin Nasal Spray to Prevent Breakthrough Pain Episodes in Patients With Radiation-induced Oropharyngeal Mucositis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breakthrough Pain
Mucositis
Radiotherapy
Chemotherapy
Head and Neck Cancer
Keywords: Mucositis
Breakthrough pain
Head Nad neck cancer
Intranasal transmucosal fentanyl in pectin
Lead sponsor: Grupo de Investigación Clínica en Oncología Radioterapia
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Pain Intensity Difference
timeFrame: 30 minutes after PecFent administration
Secondary outcomes:
measure: number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication
timeFrame: 12 episodes of breakthrough pain presenting within a maximum of 7 days.
Other outcomes:
measure: safety of intranasal transmucosal fentanyl
timeFrame: 7 days
Locations:
city: Majadahonda
country: Spain
facility: Alejandro de la Torre. Hospital Puerta de Hierro
state: Madrid
Study officials:
affiliation: GICOR & Hospital Puerta de Hierro
name: Alejandro De la Torre, MD
role: PRINCIPAL_INVESTIGATOR
References: