Clinical trial · Interventional
Standard Pain Control or Intrathecal Therapy in Controlling Pain in Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
A Randomized Study of Optimal Pain Management: Standard Pain Control Versus Early Intervention With Intrathecal Therapy in Patients With Advanced Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low enrollment
Summary
Brief summary (as posted)
RATIONALE: Giving medications in different ways may change their effectiveness in controlling pain. It is not yet known whether intrathecal therapy is more effective than standard therapy in controlling pain in patients with pancreatic cancer. PURPOSE: This randomized clinical trial is studying standard pain control to see how well it works compared with intrathecal therapy in controlling pain in patients with locally advanced, unresectable, or metastatic pancreatic cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medtronic intrathecal pump | Device | — | UNRESOLVED |
| morphine sulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- morphine
- description
- morphine given traditionally (IV, pill, patch). This is standard of care dosing.
- interventionNames
- Drug: morphine sulfate
- type
- ACTIVE_COMPARATOR
- label
- Intrathecal pump
- description
- Pump internal used to deliver morphine. This is a newer method for delivery of morphine. Morphine is FDA approved for intrathecal use. The intrathecal pump will be titrated gradually to effect by the interventional pain medicine team. These are the maximum doses and concentrations in keeping with the Polyanalgesic Consensus Conference guidelines: Dose (mg/day):15 ; Conc (mg/cc): 20
- interventionNames
- Device: Medtronic intrathecal pump
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically confirmed adenocarcinoma of the pancreas * Mixed adenocarcinoma tumors allowed provided the predominant invasive component of the tumor is adenocarcinoma * Locally advanced, unresectable, or metastatic disease * Patients must be within two months of diagnosis or have started chemotherapy within 60 days of study * Average pain score ≥ 4/10 over a 7-day period on a verbal numerical rating scale Exclusion criteria: * Known brain metastases * Tumor with clinically significant obstruction of the spinal canal PATIENT CHARACTERISTICS: Inclusion criteria: * Karnofsky performance status 60-100% * ANC ≥ 1,500 cells/mm³ * Hematocrit ≥ 28% * WBC ≥ 3,500 cells/mm³ * Platelets ≥ 90,000/mm³ * Serum creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 2.5 mg/dL * AST/ALT ≤ 5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 5 times ULN * INR ≤ 1.5 * Not pregnant or nursing * Negative pregnancy test * Mini-mental status exam score ≥ 22 Exclusion criteria: * Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy, including any of the following: * Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation * Active peptic ulcer disease * Active infections * Insensitive to opioid medication for cancer pain * Insufficient tissue or decubitus ulcer near device implantation site * Current history of substance abuse PRIOR CONCURRENT THERAPY: * Minor procedures (i.e., dental work or skin biopsy), tumor biopsies, and biliary stent placement are allowed * No prior surgical procedures affecting absorption * Prior or other concurrent pain medications are allowed * Concurrent chemotherapy or radiotherapy allowed at the discretion of the treating physician
References
Publications (0)
Data not yet available