Cancer patient
Conditions
Interventions
Trade Name: PECFENT
Pharmaceutical Form: Nasal spray
INN or Proposed INN: fentanyl
CAS Number: 990-73-8
Other descriptive name: FENTANYL
Sponsors
UNICANCER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient over 18 years old; 2. Patient followed and / or treated for a cancerous disease; 3. Patient with pain related to his cancer (localization related to the primary tumor and / or metastases); 4. Patient a. not treated with opioids (naive) b. or treated for less than 7 days with opioid extended-release therapy and / or less than 60 mg per day of oral morphine, or less than 30 mg per day of oral oxycodone, or less than mg per day of oral hydromorphone, or less than 25 µg per hour of transdermal fentanyl; 5. Patient having to perform at least one of the following examinations for a period of between 20 and 45 minutes during which the patient will be asked not to move: at. Radiation therapy session * including tomotherapy (outpatient or inpatient), b. Dosimetric scanner (hospitalized patient), c. Positron Tomography ** (PET-CT and TEMP-CT) (inpatient); 6. Affiliation to a social security scheme. * A patient who is scheduled to return to radiation therapy for multiple sessions will only be included once. ** phase of acquisition lying supine and strictly immobile in one of the cameras (TEMP OR TEP). INCLUSION / COHORT CRITERIA: Identical to the inclusion criteria of the test except 4. Patient treated for cancer pain with long-acting opioid at. for more than 7 days, b. and 60 mg or more of morphine per day, or 30 mg or more of oxycodone per day, or 8 mg of hydromorphone or more per day, or 25 microgram / h of transdermal fentanyl or more; 6. Patient who believes that he will not be able to lie down and thus make the diagnostic or therapeutic examination because of pain in this position, or Patient who, when lying supine, presents a Painful Access (Digital Scale EN> 5) corresponding to a metastatic localization or to the primary tumor, or Patient presenting a Painful Access (Digital Scale EN> 5) corresponding to a metastatic localization or to the primary tumor preventing it from continuing the diagnostic or therapeutic examination; 7. Affiliation to a social security scheme. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: 1. Patient with a contraindication to taking fentanyl acetate: Severe respiratory depression or severe obstructive pulmonary disease; 2. Patient already included once in the protocol; 3. Patient with a history of alcoholism or drug addiction; 4. Patient with self-controlled analgesic pump (PCA) opioid IV or SC; 5. Patient who does not communicate or does not understand the instructions in French; 6. Patient deprived of liberty and of age who is the subject of a measure of legal protection or unable to express his consent; 7. Pregnant patient, likely to be pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: MAIN OBJECTIVE / PHASE II TEST: To evaluate the efficacy of fentanyl citrate (FAR) administration during painful access (AD) induced by the positional requirements of diagnostic or therapeutic examinations in a group of patients with cancer who do not meet the criteria of the marketing autorization for the prescription of the FAR: - patients with less than 60 mg prolonged-release morphine; - patients with morphine sustained release for less than 7 days; - or opioid-naive patients. MAIN OBJECTIVE / COHORT: To evaluate the efficacy of FAR administration in ADs induced in the group of patients with FAR prescription under the MA (Management of ADP, in patients already having opioid-dependent less than one equivalent of 60 mg / day of oral morphine) for chronic pain of cancerous origin and for at least one week). ; Secondary Objective: SECONDARY OBJECTIVE (S) / TRIAL PHASE II AND COHORT: - Evaluate the tolerance of FAR administration during Painful Access induced by the positional requirements of diagnostic or therapeutic examinations. - Evaluate the effectiveness of FAR on pain. - Evaluate the effectiveness of FAR on anxiety. - Evaluate the percentage of relief and patient satisfaction associated with taking FAR. SECONDARY OBJECTIVE (S) / TRIAL PHASE II: - Describe the causes of failure of diagnostic or therapeutic examinations ; Primary end point(s): Efficiency is defined by success of carrying out diagnostic or therapeutic examination. A patient will be considered successful if the total planned immobilization time is respected (PET CT, TEMP CT, Radiotherapy, Tomotherapy) or if the planned tracking phase is performed (dosimetric scanner). If a patient has multiple treatments and / or imagery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The tolerance will be evaluated according to the classification of the NCI-CTC toxicity scale v4.03. - The pain will be evaluated by numerical scale (EN), during the diagnostic or therapeutic examination. - Anxiety will be assessed by the Hospital Anxiety and Depression Scale (HAD). - Relief from pain before treatment is expressed by the patient on a scale of 0% (no relief) to 100% (maximum relief). An overall satisfaction score, related to taking FAR, between 0 (not at all satisfied) and 10 (very satisfied) is also indicated by the patient. - The causes of failure of the examination will be described according to the following modalities: Tolerance problem, Patient painful (not relieved) or Other cause, if failure after the second treatment. - Unblinded success, in the Phase II study only, will be evaluated by the following question asked to the patient within 30 minutes after the end of the diagnostic or therapeutic examination, whatever its outcome (complete or failed): " In which group do you think you have been randomized? ". ; Timepoint(s) of evaluation of this end point: - The assessment of tolerance will be made from the first treatment until 4 hours after the last treatment. - The pain will be assessed during the examination at the following time: T0 (first dose of FAR treatment or Placebo), T5 (T0 + 5min), T10 (T0 + 10min), T15 (T0 + 15 min), T30 ( T0 + 30min), T60 T0 + 60min). - The anxiety will be evaluated within 30 minutes after the end of the diagnostic or therapeutic examination. - Relief from pain is expressed within 30 minutes after the end of the diagnostic or therapeutic examination. - The causes of failure of the exam will be described if failure after the second treatment take. - Blind Success, in the Phase II study only, will be eval | — |
Countries
France
Contacts
Public ContactValérie PLENCE, Project Manager
UNICANCER
Outcome results
None listed