Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy

Study Overview
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Brief Summary
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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
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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

Official Title
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Phase 3 Study Evaluating Fentanyl Transmucosal in the Prevention of Pain Induced by Mobilization During Radiotherapy in Patients With Bone Metastasis

Conditions
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Bone Metastasis

Intervention / Treatment
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* Drug: fentanyl transmucosal
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pecfent<br>Patients will receive 100 µg of transmucosal Pecfent before radiotherapy session (or 200 µg in patients with a stable opioid background pain treatment) | Drug: fentanyl transmucosal<br>* Participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during preliminary scanner session. When starting the radiotherapy session, investigator will collect the signed inform consent form, deliver the treatment, will collect pain intensity value using VAS (before and after the radiotherapy session).<br>* Other names: Pecfent;|
| Placebo Comparator: Placebo<br>Patients will receive 100 µg of transmucosal placebo before radiotherapy session or 200 µg in patients with a stable opioid background pain treatment) | Drug: Placebo<br>* Participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during preliminary scanner session. When starting the radiotherapy session, investigator will collect the signed inform consent form, deliver the treatment, will collect pain intensity value using VAS (before and after the radiotherapy session).<br>* Other names: Placebo in transmucosal use;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug efficacy | Pain Intensity Difference (PID) with the VAS considering the higher Pain Intensity (PI) score notified by the patient during the scanner and radiotherapy session | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient global satisfaction | - 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 | one week | 
| Adverse event of Pecfent | Percentage of patient with side effects due to Pecfent | one week | 
| Rescue medication | Percentage of patients needing rescue medication during radiotherapy session | 30 minutes | 
| Radiotherapy session duration | Duration of the session between the patient is discharged from the cabin until his return in the cabin | one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone metastasis, radiotherapy, pain, prevention