Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients

NCT03809455 | Withdrawn Phase 2 DMC

• 1 other identifier: UC-0106/1607 SdS 02 FARADI
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A phase II, prospective, multicentre, single-blinded, randomised study (when fentanyl citrate is used outside of its marketing authorisation) Patients will be enrolled in an observational cohort when the fentanyl citrate is used according to its marketing authorisation.

Conditions

Breakthrough Pain

Keywords

Breakthrough Pain

Outcome Measures

Primary Outcomes (1)

• Successful diagnostic or therapeutic examination

  A patient will be considered a success if the planned immobilization period is completed.

  1 hours after randomization

Study Arms (2)

FAR Arm

EXPERIMENTAL

Drug: Fentanyl citrate

Placebo Arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Fentanyl citrate DRUG

Fentanyl citrate arm (FAR Arm): one intake of fentanyl citrate 100 µg (intranasal or buccal). Placebo Arm: one intake of placebo (intranasal or buccal) The administration route will be left to the discretion of the investigator taking into account the patient's profile (capable of maintaining the sublingual tablet without swallowing, absence of nasal discharge…), and/or the patient's choice. Medication Commercial name Formulation Administration route Dose Fentanyl citrate Pecfent® Nasal spray Intranasal 100 µg Fentanyl citrate Abstral® Sublingual tablet Buccal 100 µg For the cohort the choice of treatment by FAR is at the centres discretion, according to standard of practice. Treatment duration: 1 day

FAR Arm

Placebo DRUG

one intake of placebo (intranasal or buccal)

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Patients in follow up or being treated for cancer.
• Patients with cancer-related pain (area of pain located near primary tumor or metastatic lesions).
• Patients:
• not having received any opioid treatment (opioid naïve).
• or, treated for less than 7 days by a slow-releasing/extend-release opioid treatment; and/or by less than 60 mg per day of oral morphine, or less than 30 mg/day of oral oxycodone, or less than 8 mg/day of oral hydromorphone, or less than 25 µg/h of transdermal fentanyl.
• Patients need to have at least one of the following interventions, lasting between 25 and 45 minutes during which they will be request to not move:
• Radiotherapy session\*, including tomography (patients hospitalized or treated as outpatients).
• Dosimetric scanner (hospitalized patients).
• Positron-emission tomography\*\* (PET): PET-computed tomography \[CT\] scan and single photon emission computed tomography \[SPECT\]-CT scan (hospitalized patients).
• Public health insurance coverage.
• (\*) A patient who has numerous radiotherapy sessions can only be included once; (\*\*) with acquisition phase in a prostrate or decubitus dorsal position and strictly immobile in one of the cameras (PET or SPECT).
• \. Patients treated with a slow-releasing/extended-release opioid for:
• more than 7 days.
• and with at least 60 mg per day of oral morphine, or at least 30 mg/day of oral oxycodone, or at least 8 mg/day of oral hydromorphone, or at least 25 µg/h of transdermal fentanyl.

You may not qualify if:

• Patients with contraindication for the administration of fentanyl citrate: severe respiratory depression or a severe obstructive pulmonary disease.
• Patients who have already participated in this study.
• Patients with a history of alcoholism or substance/drug dependence.
• Patients with an intravenous or subcutaneous opioid patient-controlled analgesic (PCA) pump.
• Patients unable to communicate or understand instructions in French.
• Patients deprived of their liberty or under protective custody or guardianship, or unable to provide their consent for study participation.
• Patients who are pregnant or breast-feeding.

Sponsors & Collaborators

• UNICANCER: lead

MeSH Terms

Conditions

Breakthrough Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A phase II, prospective, multicentre, single-blinded, randomised study (when fentanyl citrate is used outside of its marketing authorisation) Patients will be enrolled in an observational cohort when the fentanyl citrate is used according to its marketing authorisation. The study will randomise patients (2:1; FAR Arm: Placebo Arm) Stratified by: * Centre * Type of examination: diagnostic (PET-CT scan or SPECT-CT scan) versus therapeutic (radiotherapy, tomotherapy, or dosimetric scanner)

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: January 18, 2019
• Study Start: February 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2023
• Last Updated: April 22, 2020

Record last verified: 2020-04