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

Centre Henri Becquerel

Status and phase: Completed; Phase 3

Conditions: Bone Metastasis

Treatments: Drug: fentanyl transmucosal; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02426697

CHB14.03

Details and patient eligibility

About

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

Full 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

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 2 patient groups, including a placebo group

Pecfent

Experimental group

Description:

Patients will receive 100 µg of transmucosal Pecfent before radiotherapy session (or 200 µg in patients with a stable opioid background pain treatment)

Treatment:

Drug: fentanyl transmucosal

Placebo

Placebo Comparator group

Description:

Patients will receive 100 µg of transmucosal placebo before radiotherapy session or 200 µg in patients with a stable opioid background pain treatment)

Treatment:

Drug: Placebo