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Completed

NCT Number: NCT02426697

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

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

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Key information

Conditions

Bone Metastasis Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Henri Becquerel

Rouen, 76038, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fentanyl transmucosal

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: PARABONE

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 27, 2015
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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