Breakthrough Pain, Chemotherapy, Head and Neck Cancer, Mucositis, Radiotherapy
Conditions
Keywords
Mucositis, Breakthrough pain, Head Nad neck cancer, Intranasal transmucosal fentanyl in pectin
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.
Interventions
None listed
Sponsors
Grupo de Investigación Clínica en Oncología Radioterapia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Difference | 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
| Measure | Time frame | Description |
|---|---|---|
| number of episodes of breakthrough pain requiring additional (rescue) analgesic treatment after administration of the study medication | 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
| Measure | Time frame | Description |
|---|---|---|
| safety of intranasal transmucosal fentanyl | 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) |
Countries
Spain
Outcome results
None listed