Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy
- Registration Number
- NCT02426697
- Lead Sponsor
- Centre Henri Becquerel
- Brief Summary
The clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the prevention of pain induced by mobilization in patients receiving a bone metastasis radiation for bone metastasis irradiations
- Detailed Description
Participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during the preliminary scanner session that will be held before radiotherapy session(s). Patients with a VAS≤ 3 will be excluded.
PecFent and Placebo will be delivered by Archimedes Pharma When starting the radiotherapy session(s) (2 days after the preliminary scanner session), the medic will collect the patient signed informed consent, will deliver the treatment 1 dose of fentanyl transmucosal (Pecfent® ) 100µg in naive patients or 1 dose of Pecfent® 200µg in patient with a stable opioid background pain treatment or placebo) and will collect pain intensity value with a patient VAS collected before and at the end of the radiotherapy session. Finally patient \& radiotherapists global satisfaction will be collected An assessment a week the end of the radiotherapy session will be assessed by investigator consisting in a Patient global satisfaction
Study follow up:
Patients will receive a phone call a week after the radiotherapy session to collect patient global satisfaction score related with the global management of the radiotherapy session
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Male or female
- More than 18 years old
- Proven histological cancer with bone metastasis
- SignedInform consent form
- Patient with pain assed as VAS Superior to 3 when positioning the patient in the preliminary scanner session
- VAS>3 before radiotherapy treatment (establishment of an appropriate analgesic treatment) (session
- Any SAO treatment on going
- Pregnant or lactating woman
- Hypersensitivity or safety issues to any opioïd treatment
- Poor nasal mucosa (defined on clinical doctor assessment)
- Severe obstructive lung conditions or respiratory depression
- Renal insufficiency with creatinine clearance inferior to 45 ml/min
- Hepatic insufficiency
- Patient misunderstanding of the content and objective of the trial
- Patient under supervision or guardianship
- SAO intake 4 hours before the radiotherapy session
- Patient participating to any other pain management trial
- Morphine pump usage
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pecfent fentanyl transmucosal Patients will receive 100 µg of transmucosal Pecfent before radiotherapy session (or 200 µg in patients with a stable opioid background pain treatment) Placebo Placebo Patients will receive 100 µg of transmucosal placebo before radiotherapy session or 200 µg in patients with a stable opioid background pain treatment)
- Primary Outcome Measures
Name Time Method Drug efficacy 30 minutes Pain Intensity Difference (PID) with the VAS considering the higher Pain Intensity (PI) score notified by the patient during the scanner and radiotherapy session
- Secondary Outcome Measures
Name Time Method Rescue medication 30 minutes Percentage of patients needing rescue medication during radiotherapy session
Radiotherapy session duration one hour Duration of the session between the patient is discharged from the cabin until his return in the cabin
Patient global satisfaction one week - Patient Global Satisfaction Score \[0 (not satisfied) to 5 (very satisfied) one week after the radiotherapy session. Patients will receive a phone call a week after the radiotherapy session to collect patient global satisfaction score related with the global management of the radiotherapy session
Adverse event of Pecfent one week Percentage of patient with side effects due to Pecfent
Trial Locations
- Locations (1)
Centre Henri Becquerel
🇫🇷Rouen, France