Status:
WITHDRAWN
Effectiveness and Tolerance of Fentanyl Citrate in Painful Pain Induced During Diagnostic or Therapeutic Examinations in Cancer Patients
Lead Sponsor:
UNICANCER
Conditions:
Breakthrough Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 inte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03809455
Start Date
February 1 2020
End Date
February 1 2023
Last Update
April 22 2020
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