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

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

Study Overview

• Status: Unknown
• Conditions: Bone Metastasis
• Intervention / Treatment: Drug: fentanyl transmucosal; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sébastien Thureau, MD; Phone Number: +33232082992; Email: sebastien.thureau@chb.unicancer.fr

Study Locations

• France
  • Rouen, France, 76038
    • Recruiting
    • Centre Henri Becquerel
    • Contact: Sebastien Thureau, Md; Phone Number: 0232082992; Email: sebastien.thureau@chb.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pecfent; 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; 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).; Other Names: Pecfent
Placebo Comparator: Placebo; 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; 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).; Other Names: Placebo in transmucosal use

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: April 22, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Actual): July 23, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: bone metastasis, radiotherapy, pain, prevention
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: CHB14.03