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A Randomized Study of Optimal Pain Management: Standard Pain Control Versus Early Intervention With Intrathecal Therapy in Patients With Advanced Pancreatic Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Pain, Pancreatic Cancer

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Trial Information

A Randomized Study of Optimal Pain Management: Standard Pain Control Versus Early Intervention With Intrathecal Therapy in Patients With Advanced Pancreatic Cancer


OBJECTIVES:

Primary

- To compare the effectiveness of pain control comprising intrathecal opioid delivery
versus the standard analgesia-delivery method in patients with locally advanced,
unresectable, or metastatic pancreatic cancer.

Secondary

- To assess the difference of a total amount of opioid consumption (parenteral morphine
equivalent) between two different opioids-delivery groups at one month of treatment.

- To assess the average of percent change in Karnofsky performance status with respect to
the baseline status between two different analgesic-delivery groups at one month of
treatment.

- To assess the difference in quality of life between two different opioids-delivery
groups at one month of treatment using the EORTC QLQ-C30.

- To assess overall survival of these patients.

- To assess the safety profile of two different analgesic-delivery methods (i.e., adverse
event and serious adverse event).

OUTLINE: Patients are stratified according to Karnofsky performance status (60-80% vs >
80%). Patients are randomized to 1 of 2 treatment arms.

- Arm I (standard pain management): Patients are evaluated by the JHH Pain Medicine
Integrated Team for pain, for the potential of diagnostic/neurolytic celiac plexus
block, and undergo the institution of or modification of or continuation and titration
of oral or parenteral analgesics. Patients undergo a limited, problem-oriented physical
exam including weight, vital signs, Karnofsky performance status (KPS), assessment of
previously abnormal findings or new complaints, pain scores, analgesia consumption,
side effects (i.e., sleepiness, nausea, pruritus, and constipation), and
quality-of-life score (EORTC QLQ-C30) once every 2 weeks for 3 months and then once a
month thereafter. Patients also keep a diary of pain scores and side effects during the
trial. Patients may have their treatment titrated as needed to control their pain.
Patients who are not adequately pain controlled or develop debilitating side effects
from their therapy may be managed by adjuvant analgesics or be allowed to crossover
into the treatment arm of the study to provide compassionate care.

- Arm II (intrathecal therapy): Patients undergo implantation of a Medtronic intrathecal
pump and catheter system for delivery of morphine sulfate directly into the spinal
fluid. Following implantation, patients undergo a limited, problem-oriented physical
exam including vital signs, KPS, assessment of previously abnormal findings or new
complaints, pain scores, analgesia consumption, and quality-of life-score (EORTC
QLQ-C30) once every 2 weeks for 3 months and then once a month thereafter. Patients are
also evaluated by the Interventional Pain Treatment Team for wound status, presence of
symptoms of post-dural puncture headache, signs of infection, or meningitis. Patients
are followed by the JHH Pain Medicine Integrated Team for evaluation of pain and for
institution of or modification of or continuation and titration of oral or parenteral
analgesics.

After completion of study treatment, patients are followed for 1 year.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Pain as verbally reported by the patient on a 0-10 verbal scale

Outcome Description:

Will perform pain assessments at baseline and at follow-up visits. Follow-up visits are approximately every two weeks for the first month, monthly for the next two months and every three months thereafter. The final visit will be at 12 months.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Michael Erdek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

JHOC-J0724 CDR0000593173

NCT ID:

NCT00660348

Start Date:

March 2008

Completion Date:

March 2011

Related Keywords:

  • Pain
  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • adenocarcinoma of the pancreas
  • pain
  • stage II pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410