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 : Unknown
Verified July 2018 by Centre Henri Becquerel.
Recruitment status was: Recruiting
First Posted : April 27, 2015
Last Update Posted : July 23, 2018
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Condition or disease | Intervention/treatment | Phase |
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Bone Metastasis | Drug: fentanyl transmucosal Drug: Placebo | Phase 3 |
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 (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 |

Arm | Intervention/treatment |
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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)
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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)
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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 |
- 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
- 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
- Adverse event of Pecfent [ Time Frame: one week ]Percentage of patient with side effects due to Pecfent
- Rescue medication [ Time Frame: 30 minutes ]Percentage of patients needing rescue medication during radiotherapy session
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Sébastien Thureau, MD | +33232082992 | sebastien.thureau@chb.unicancer.fr | |
Contact: Doriane Richard | +33232082985 | doriane.richard@chb.unicancer.fr |
France | |
Centre Henri Becquerel | Recruiting |
Rouen, France, 76038 | |
Contact: Sebastien Thureau, Md 0232082992 sebastien.thureau@chb.unicancer.fr | |
Principal Investigator: Sebastien Thureau, MD |
Principal Investigator: | Sébastien Thureau, MD | Centre Henri Becquerel |
Responsible Party: | Centre Henri Becquerel |
ClinicalTrials.gov Identifier: | NCT02426697 |
Other Study ID Numbers: |
CHB14.03 |
First Posted: | April 27, 2015 Key Record Dates |
Last Update Posted: | July 23, 2018 |
Last Verified: | July 2018 |
bone metastasis, radiotherapy, pain, prevention |
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 |