Clinical trial NCT02426697: Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy
Official title: Phase 3 Study Evaluating Fentanyl Transmucosal in the Prevention of Pain Induced by Mobilization During Radiotherapy in Patients With Bone Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bone Metastasis
Keywords: bone metastasis, radiotherapy, pain, prevention
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2015-04-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Drug efficacy
timeFrame: 30 minutes
Secondary outcomes:
measure: Patient global satisfaction
timeFrame: one week
measure: Adverse event of Pecfent
timeFrame: one week
measure: Rescue medication
timeFrame: 30 minutes
measure: Radiotherapy session duration
timeFrame: one hour
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Sébastien Thureau, MD
role: PRINCIPAL_INVESTIGATOR
References: