Pain Clinical Trial
Official title:
A Randomized Study of Optimal Pain Management: Standard Pain Control Versus Early Intervention With Intrathecal Therapy in Patients With Advanced Pancreatic Cancer
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects Per Arm With Decrease in Pain Scores | The primary objective of this study is to compare the effectiveness of pain control between intrathecal opioid delivery and standard analgesia delivery method in patients with locally advanced unresectable or metastatic pancreatic cancer. The primary end point is the number of subjects on each arm showing a decrease in the change in VAS self-assessment pain intensity rating (VAS pain rating) at one month from initial treatment with respect to the baseline pain score. The change is defined as (the Pain Score at one month of the treatment - the Pain Score at baseline). Serial pain scores will be collected at all assessment time points. Min: zero cm. Max 10cm. A higher value means worse pain. Subjects on each arm will report pain on a 10 cm Visual Analogue Scale (VAS) pain rating scale, by making a mark on the 10cm horizontal line with a pen and study team will measure distance from the mark to the start of the scale, which will indicate pain score (eg 1 cm, 3 cm 6 cm, etc.). | 1 month | No |
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