Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer (NCT07733427) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer
France40 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Subject aged over 20 years
* Patient with histologically confirmed pancreatic carcinoma
* Chronic cancer-related pain that is inadequately controlled by standard treatment or for whom analgesics are contraindicated.
* EMO \< 120 mg/day Patients experiencing side effects: sedation, vomiting, constipation, or an allergy to morphine.
* Signed informed consent
* Participants affiliated with or eligible for a social security scheme
* Agree to complete the various study questionnaires
Exclusion Criteria:
Patients under the age of 20.
* Contraindications to intratracheal analgesia
* Acute respiratory infection
* Uncontrolled coagulation disorder
* Pregnancy or breastfeeding
* Unable to comply with medical follow-up for the study.
* Adults who are legally protected, under guardianship or under a conservatorship
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Edmonton Symptom Assessment System (ESAS) - Pain Subscore
Timeframe: Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months
Trial details
NCT IDNCT07733427
SponsorClinique Bizet
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-03
Contact for this trial
Bouchra BENKESSOU Chef de projet Recherche Clinique