Back to resultsEffectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients (FARADI)
Primary Purpose
Breakthrough Pain
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fentanyl citrate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Breakthrough Pain focused on measuring Breakthrough Pain
Eligibility Criteria
Inclusion Criteria:
- 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).
Inclusion criteria (cohort):
As for the inclusion criteria for the phase II study, with the following modifications:
4. 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.
5. Patients who believes that they are cannot assume a prostrate or decubitus dorsal position for a diagnostic or therapeutic examination/intervention due to the pain they will experienced in this position,
Or
Patients experience breakthrough pain (numerical pain scale 5), in a region corresponding to the localization of the metastatic lesions or the primary tumor, when they assume a prostrate/decubitus dorsal position,
Or
Patients who have breakthrough pain (numerical pain scale 5) in a region corresponding to the localization of the metastatic lesions or the primary tumor that prevents the completion of a diagnostic or therapeutic examination/intervention.
6. Public health insurance coverage.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FAR Arm
Placebo Arm
Arm Description
Outcomes
Primary Outcome Measures
Successful diagnostic or therapeutic examination
A patient will be considered a success if the planned immobilization period is completed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03809455
Brief Title
Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients
Acronym
FARADI
Official Title
Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study was cancelled by Sponsor.
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Primary objective (phase II trial):
Evaluate the efficacy of an administration of fentanyl citrate to alleviate breakthrough pain caused by positional requirements of a diagnostic or therapeutic intervention/examination in cancer patients who do not meet the prescription criteria for fentanyl citrate's marketing authorisation, as follows:
Patients having received less than 60 mg of slow-release/extended-release morphine.
Patients having received slow-release/extended-release morphine for less than 7 days.
Patients who have not received any opioid treatment.
Primary objective (cohort):
Evaluate the efficacy of an administration of fentanyl citrate to alleviate breakthrough pain caused by positional requirements of a diagnostic or therapeutic intervention/examination in cancer patients when used within the marketing authorisation, as follows:
Patients having at least 60 mg of slow-release/extended-release morphine.
Patients having received slow-release/extended-release morphine for at least 7 days.
Patients who have already received an opioid treatment (at least equivalent to 60 mg /day of oral morphine) for chronic cancer-related pain for at least 7 days.
Secondary objectives (phase II and cohort):
Evaluate the tolerance of the administration of fentanyl citrate when used to alleviate breakthrough pain caused by positional requirements of a diagnostic or therapeutic intervention/examination in cancer patients.
Evaluate the efficacy of fentanyl citrate for reducing pain.
Evaluate the efficacy of fentanyl citrate for reducing anxiety.
Evaluate the percentage of relief and patients' satisfaction related to the administration of fentanyl citrate.
Secondary objectives (phase II only):
• Describe the reasons why the diagnostic or therapeutic intervention/examination failed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breakthrough Pain
Keywords
Breakthrough Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FAR Arm
Arm Type
Experimental
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fentanyl citrate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one intake of placebo (intranasal or buccal)
Primary Outcome Measure Information:
Title
Successful diagnostic or therapeutic examination
Description
A patient will be considered a success if the planned immobilization period is completed.
Time Frame
1 hours after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Inclusion criteria (cohort):
As for the inclusion criteria for the phase II study, with the following modifications:
4. 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.
5. Patients who believes that they are cannot assume a prostrate or decubitus dorsal position for a diagnostic or therapeutic examination/intervention due to the pain they will experienced in this position,
Or
Patients experience breakthrough pain (numerical pain scale 5), in a region corresponding to the localization of the metastatic lesions or the primary tumor, when they assume a prostrate/decubitus dorsal position,
Or
Patients who have breakthrough pain (numerical pain scale 5) in a region corresponding to the localization of the metastatic lesions or the primary tumor that prevents the completion of a diagnostic or therapeutic examination/intervention.
6. Public health insurance coverage.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients
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