Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy (PARABONE)
Primary Purpose
Bone Metastasis
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
fentanyl transmucosal
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bone Metastasis focused on measuring bone metastasis, radiotherapy, pain, prevention
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
Sites / Locations
- Centre Henri BecquerelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pecfent
Placebo
Arm Description
Patients will receive 100 µg of transmucosal Pecfent before radiotherapy session (or 200 µg in patients with a stable opioid background pain treatment)
Patients will receive 100 µg of transmucosal placebo before radiotherapy session or 200 µg in patients with a stable opioid background pain treatment)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Adverse event of Pecfent
Percentage of patient with side effects due to Pecfent
Rescue medication
Percentage of patients needing rescue medication during radiotherapy session
Radiotherapy session duration
Duration of the session between the patient is discharged from the cabin until his return in the cabin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02426697
Brief Title
Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy
Acronym
PARABONE
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastasis
Keywords
bone metastasis, radiotherapy, pain, prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pecfent
Arm Type
Experimental
Arm Description
Patients will receive 100 µg of transmucosal Pecfent before radiotherapy session (or 200 µg in patients with a stable opioid background pain treatment)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive 100 µg of transmucosal placebo before radiotherapy session or 200 µg in patients with a stable opioid background pain treatment)
Intervention Type
Drug
Intervention Name(s)
fentanyl transmucosal
Other Intervention Name(s)
Pecfent
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo in transmucosal use
Intervention Description
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).
Primary Outcome Measure Information:
Title
Drug efficacy
Description
Pain Intensity Difference (PID) with the VAS considering the higher Pain Intensity (PI) score notified by the patient during the scanner and radiotherapy session
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Patient global satisfaction
Description
- 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
Time Frame
one week
Title
Adverse event of Pecfent
Description
Percentage of patient with side effects due to Pecfent
Time Frame
one week
Title
Rescue medication
Description
Percentage of patients needing rescue medication during radiotherapy session
Time Frame
30 minutes
Title
Radiotherapy session duration
Description
Duration of the session between the patient is discharged from the cabin until his return in the cabin
Time Frame
one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien Thureau, MD
Phone
+33232082992
Email
sebastien.thureau@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Thureau, MD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastien Thureau, Md
Phone
0232082992
Email
sebastien.thureau@chb.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Sebastien Thureau, MD
12. IPD Sharing Statement
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Pain Management With Pecfent in the Prevention of Pain Induced by Position in Radiotherapy
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