ot applicable

Phase 1

• Conditions: Cancer patient; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001520-66-FR
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-06
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 180

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified