Bone Metastasis
Conditions
Keywords
bone metastasis, radiotherapy, pain, prevention
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
Interventions
DRUGfentanyl transmucosal
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).
DRUGPlacebo
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).
Sponsors
Centre Henri Becquerel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
France
Outcome results
None listed