Clinical Trial

Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer

Study acronym: PIT
Not Yet Recruiting
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Summary
The aim of this clinical trial is to assess the effectiveness of intratracheal analgesia on pain intensity in cancer patients, from the start of treatment up to 3 months. It will also investigate the safety of this technique. The main questions it seeks to answer are as follows: What is the impact on the use of opioid analgesics, and can this be measured? What is the quality of life? What is the quality of sleep, and can this be assessed? How does the patient's weight change? Is the patient satisfied? What is the patient's overall survival? The researchers will assess the equivalent daily dose of morphine (mg/day) between enrolment and follow-up visits, as well as the number of patients requiring an escalation of analgesic treatment. Overall quality of life score measured using the ESAS questionnaire between enrolment and follow-up visits; satisfaction assessed using a numerical satisfaction scale (0-10); sleep quality assessed using the ISI questionnaire; and the tolerability and safety of the technique assessed by monitoring adverse events. Eligible participants: Following implantation of the intrathecal pump, participants will have scheduled consultations at day 30, then at 3, 6, 9 and 12 months, with questionnaires to be completed.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-08-01
Trial Details
NCT Number NCT07733427
Lead Sponsor Clinique Bizet
Conditions Pancreatic Cancer Pain, Intrathecal Analgesic, Intrathecal Administration of the Drug, Pancreatic Carcinoma
Enrollment 40 participants
Start Date 2026-06
Primary Completion 2027-03 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-31