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

NCT07733427 | Not Yet Recruiting

• 1 other identifier: 2026-A00905-46
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pancreatic Cancer Pain; Intrathecal Analgesic; Intrathecal Administration of the Drug; Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in Edmonton Symptom Assessment System (ESAS) - Pain Subscore

  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).

  Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

Secondary Outcomes (8)

• Change in Edmonton Symptom Assessment System (ESAS) Overall Quality of Life Score

  Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

• Proportion of Patients Requiring Pain Treatment Escalation

  Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

• Change in Daily Morphine Equivalent Dose (MED)

  Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

• Change in Sleep Quality Score Insomnia Severity Index (ISI)

  Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

• Change in Body Weight

  Telephone call between Week 1 and Week 12, and questionnaires at Day 30, 3 months, 6 months, 9 months and 12 months

Study Arms (1)

Intrathecal catheter implantable pump

EXPERIMENTAL

Administration of the medicine via an intrathecal catheter connected to an implantable pump

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

Interventions

Intrathecal catheter connected to an implantable pump DEVICE

Epidural puncture (AL injection), followed by a lumbar puncture and collection of cerebrospinal fluid. Positioning of the catheter behind the spinal cord at the desired metameric level for the pancreas (T5-T7), and positioning of the pump in the flank or buttock.

Intrathecal catheter implantable pump

Administration of medication, including analgesics, via an intrathecal catheter connected to an implantable pump or via periodic injections DRUG

Medications are administered via an intrathecal catheter connected to an implantable pump or via periodic injections; the patient is admitted to hospital with morphine (IV, PO, transdermal) discontinued on entry to the unit (the same applies to methadone). Depending on the condition of the patient's abdominal skin (stoma, multiple injections, etc.) and any foreseeable technical difficulties during MRI scanning (in the left or right lateral positions), the procedure is performed under fluoroscopy, with appropriate antibiotic prophylaxis, under local anaesthesia, epidural anaesthesia and light sedation. Product used, dosage and frequency: Opioids: μ and δ receptors: Morphine sulphate: 50 mg/ml Ca++ channels: ziconotide: initial dose 0.5 µg/day Sodium channels: 1% ropivacaine As with a patient-controlled analgesia (PCA) system: Continuous infusion + bolus or sequential boluses Patient education on the use of the pump during their hospital stay.

Intrathecal catheter implantable pump

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Bizet: lead

Study Sites (3)

Benkessou

Paris, 75016, France

Location

Bizet Clinic

Paris, 75016, France

Location

Clinique Bizet

Paris, 75016, France

Location

Related Publications (11)

• Park 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 RESULT

• Bruel 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 RESULT

• Cohen SP, Dragovich A. Intrathecal analgesia. Anesthesiol Clin. 2007 Dec;25(4):863-82, viii. doi: 10.1016/j.anclin.2007.07.001.

  PMID: 18054150 RESULT

• Smith 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 RESULT

• Rizvi 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 RESULT

• Kroenke 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]

  RESULT

• Haan 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.

  PMID: 10642496 RESULT

• Carvajal G, Dupoiron D, Seegers V, Lebrec N, Bore F, Dubois PY, Leblanc D, Delorme T, Jubier-Hamon S. Intrathecal Drug Delivery Systems for Refractory Pancreatic Cancer Pain: Observational Follow-up Study Over an 11-Year Period in a Comprehensive Cancer Center. Anesth Analg. 2018 Jun;126(6):2038-2046. doi: 10.1213/ANE.0000000000002903.

  PMID: 29543644 RESULT

• Bruera E, Kim HN. Cancer pain. JAMA. 2003 Nov 12;290(18):2476-9. doi: 10.1001/jama.290.18.2476. No abstract available.

  PMID: 14612485 RESULT

• Caraceni A, Portenoy RK; a working group of the IASP Task Force on Cancer Pain. An international survey of cancer pain characteristics and syndromes. IASP Task Force on Cancer Pain. International Association for the Study of Pain. Pain. 1999 Sep;82(3):263-274. doi: 10.1016/S0304-3959(99)00073-1.

  PMID: 10488677 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Bouchra BENKESSOU Chef de projet Recherche Clinique

CONTACT

+33 7 64 48 60 16; b.benkessou@hexagone-sante-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 29, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-07

Locations

FR (3)