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

Sponsor

Centre Henri Becquerel (Other)

Overall Status

Unknown status

CT.gov ID

NCT02426697

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Bone Metastasis	Drug: fentanyl transmucosal Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Jun 1, 2019

Arms and Interventions

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

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

Other Names:

Placebo in transmucosal use

Outcome Measures

Primary Outcome Measures

Drug efficacy [30 minutes]
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 [one week]
- 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 [one week]
Percentage of patient with side effects due to Pecfent
Rescue medication [30 minutes]
Percentage of patients needing rescue medication during radiotherapy session
Radiotherapy session duration [one hour]
Duration of the session between the patient is discharged from the cabin until his return in the cabin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Henri Becquerel	Rouen		France	76038

Sponsors and Collaborators

Centre Henri Becquerel

Investigators

Principal Investigator: Sébastien Thureau, MD, Centre Henri Becquerel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Henri Becquerel

ClinicalTrials.gov Identifier:

NCT02426697

Other Study ID Numbers:

CHB14.03

First Posted:

Apr 27, 2015

Last Update Posted:

Jul 23, 2018

Last Verified:

Jul 1, 2018

Keywords provided by Centre Henri Becquerel

bone metastasis, radiotherapy, pain, prevention

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 23, 2018