Bone Metastasis Clinical Trial
Official title:
Phase 3 Study Evaluating Fentanyl Transmucosal in the Prevention of Pain Induced by Mobilization During Radiotherapy in Patients With Bone Metastasis
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
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
;
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