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

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ClinicalTrials.gov Identifier: NCT02426697
Recruitment Status : Recruiting
First Posted : April 27, 2015
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Placebo in transmucosal use


Outcome Measures
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Primary Outcome Measures :
  1. Drug efficacy [ Time Frame: 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 :
  1. Patient global satisfaction [ Time Frame: 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

  2. Adverse event of Pecfent [ Time Frame: one week ]
    Percentage of patient with side effects due to Pecfent

  3. Rescue medication [ Time Frame: 30 minutes ]
    Percentage of patients needing rescue medication during radiotherapy session

  4. Radiotherapy session duration [ Time Frame: one hour ]
    Duration of the session between the patient is discharged from the cabin until his return in the cabin


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426697


Contacts
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Contact: Sébastien Thureau, MD +33232082992 sebastien.thureau@chb.unicancer.fr
Contact: Doriane Richard +33232082985 doriane.richard@chb.unicancer.fr

Locations
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France
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Sebastien Thureau, Md    0232082992    sebastien.thureau@chb.unicancer.fr   
Principal Investigator: Sebastien Thureau, MD         
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
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Principal Investigator: Sébastien Thureau, MD Centre Henri Becquerel
More Information
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Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT02426697     History of Changes
Other Study ID Numbers: CHB14.03
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Keywords provided by Centre Henri Becquerel:
bone metastasis, radiotherapy, pain, prevention
Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Fentanyl
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics