An observational study in Breakthrough Pain, Mucositis and Radiotherapy, sponsored by Grupo de Investigación Clínica en Oncología Radioterapia. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-03-17.
Sponsored by Grupo de Investigación Clínica en Oncología Radioterapia · Observational
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
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.
34 studies on the registry are indexed under Breakthrough Pain; 4 are open to participants now.
This study's enrollment of 33 is below the median of 125 across 10 observational studies indexed under Breakthrough Pain.
Browse Breakthrough Pain studies →Grupo de Investigación Clínica en Oncología Radioterapia is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Pain Intensity Difference
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
Time frame: 30 minutes after PecFent administration
number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication
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).
Time frame: 12 episodes of breakthrough pain presenting within a maximum of 7 days.
safety of intranasal transmucosal fentanyl
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)
Time frame: 7 days
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Grupo de Investigación Clínica en Oncología Radioterapia