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

Bone Metastasis Clinical Trial

— PARABONE  

Official title:

Phase 3 Study Evaluating Fentanyl Transmucosal in the Prevention of Pain Induced by Mobilization During Radiotherapy in Patients With Bone Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02426697
• Other study ID #: CHB14.03
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: June 2019

Study information

• Verified date: July 2018
• Source: Centre Henri Becquerel
• Contact: Sébastien Thureau, MD
• Phone: +33232082992
• Email: sebastien.thureau[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastasis
• Bone Neoplasms
• Neoplasm Metastasis

Intervention

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).
• 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).

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adverse event of Pecfent	Percentage of patient with side effects due to Pecfent	one week
Secondary	Rescue medication	Percentage of patients needing rescue medication during radiotherapy session	30 minutes
Secondary	Radiotherapy session duration	Duration of the session between the patient is discharged from the cabin until his return in the cabin	one hour