Clinical trial · Interventional
Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer
A Pilot Study Aimed at Evaluating the Effectiveness of AIT in the Treatment of Pain Related to Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrathecal Administration of the Drug | — | UNRESOLVED | — |
| Intrathecal Analgesic | — | UNRESOLVED | — |
| Pancreatic Cancer Pain | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Pancreatic Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections | Drug | — | UNRESOLVED |
| Intrathecal catheter connected to an implantable pump | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intrathecal catheter implantable pump
- description
- Administration of the medicine via an intrathecal catheter connected to an implantable pump
- interventionNames
- Device: Intrathecal catheter connected to an implantable pump
- Drug: Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections
Primary outcomes (1)
- measure
- 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
- description
- Change in pain intensity score measured by the ESAS subscale from baseline to follow-up visits. Unit of Measure: Score on a scale (0 to 10) Scale Range (Minimum and Maximum Values): 0 to 10 Direction of Scores: Higher scores mean a worse outcome (greater pain intensity).
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (11)
- RESULTPark J, Park EY, Han SS, Park HM, Lee M, Lee SA, Kim SW, Kim DH, Park SJ. Randomized controlled study comparing the analgesic effects of intravenous patient-controlled analgesia and patient-controlled epidural analgesia after open major surgery for pancreatobiliary cancer. HPB (Oxford). 2022 Aug;24(8):1238-1244. doi: 10.1016/j.hpb.2022.01.013. Epub 2022 Feb 3. PMID 35183448
- RESULTBruel BM, Burton AW. Intrathecal Therapy for Cancer-Related Pain. Pain Med. 2016 Dec;17(12):2404-2421. doi: 10.1093/pm/pnw060. Epub 2016 Apr 28. PMID 28025375
- RESULTCohen SP, Dragovich A. Intrathecal analgesia. Anesthesiol Clin. 2007 Dec;25(4):863-82, viii. doi: 10.1016/j.anclin.2007.07.001. PMID 18054150
- RESULTSmith HS, Deer TR, Staats PS, Singh V, Sehgal N, Cordner H. Intrathecal drug delivery. Pain Physician. 2008 Mar;11(2 Suppl):S89-S104. PMID 18443642
- RESULTRizvi S, Kumar K. History and present state of targeted intrathecal drug delivery. Curr Pain Headache Rep. 2015;19(2):474. doi: 10.1007/s11916-014-0474-8. PMID 25638694
- RESULTKroenke K, Theobald D, Wu J, Loza JK, Carpenter JS, Tu W. L'association de la dépression et de la douleur avec la qualité de vie liée à la santé, le handicap et l'utilisation des soins de santé chez les patients atteints de cancer. J gestion des symptômes de douleur. 2010; 40(3):327-41. [DOI] [Article gratuit PMC] [PubMed] [Google Scholar][Liste des références]
- RESULT-Roberto A, Greco MT, Uggeri S, Cavuto S, Deandrea S, Corli O, et al. Revue systématique vivante pour évaluer le sous-traitement analgésique chez les patients atteints de cancer. Pratique de la douleur. 2022; 22(4):487-96. [DOI] [PubMed] [Google Scholar][Liste de références]
- RESULTHaan S, Kortylewski M, Behrmann I, Muller-Esterl W, Heinrich PC, Schaper F. Cytoplasmic STAT proteins associate prior to activation. Biochem J. 2000 Feb 1;345 Pt 3(Pt 3):417-21.