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Standard Pain Control or Intrathecal Therapy in Controlling Pain in Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00660348
Recruitment Status : Terminated (Low enrollment)
First Posted : April 17, 2008
Results First Posted : October 8, 2014
Last Update Posted : October 8, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Pain
Pancreatic Cancer
Interventions Drug: morphine sulfate
Device: Medtronic intrathecal pump
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Morphine Intrathecal Pump
Hide Arm/Group Description

morphine given traditionally (IV, pill, patch)

morphine sulfate: This is morphine given in the traditional methods.

Pump internal used to deliver morphine. This is a newer method for delivery of morphine.

Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine.

Period Title: Overall Study
Started 1 0
Completed 0 0
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Morphine Intrathecal Pump Total
Hide Arm/Group Description

morphine given traditionally (IV, pill, patch)

morphine sulfate: This is morphine given in the traditional methods.

Pump internal used to deliver morphine. This is a newer method for delivery of morphine.

Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine.

Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 0 participants 1 participants
55
(55 to 55)
55
(55 to 55)
[1]
Measure Description: Years
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
<=18 years 0 0
Between 18 and 65 years 1 1
>=65 years 0 0
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female 1 1
Male 0 0
Race (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
American Indian or Alaska Native 0 0
Asian 0 0
Native Hawaiian or Other Pacific Islander 0 0
Black or African American 0 0
White 1 1
More than one race 0 0
Unknown or Not Reported 0 0
Ethnicity (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Hispanic or Latino 0 0
Not Hispanic or Latino 1 1
Unknown or Not Reported 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Number of Subjects Per Arm With Decrease in Pain Scores
Hide Description 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.).
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
One subject was enrolled, and baseline pain score was obtained on questionnaire, but the subject came off-study before follow-up pain score could be collected. Study terminated shortly thereafter. No outcome data were collected.
Arm/Group Title Morphine Intrathecal Pump
Hide Arm/Group Description:

morphine given traditionally (IV, pill, patch). This is standard of care dosing.

morphine sulfate: This is morphine given in the traditional methods.

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

Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Morphine Intrathecal Pump
Hide Arm/Group Description

morphine given traditionally (IV, pill, patch)

morphine sulfate: This is morphine given in the traditional methods.

Pump internal used to deliver morphine. This is a newer method for delivery of morphine.

Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine.

All-Cause Mortality
Morphine Intrathecal Pump
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Morphine Intrathecal Pump
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/0    
Gastrointestinal disorders     
epigastric pain (upper quadrant)  [1]  1/1 (100.00%)  1 0/0  0
Indicates events were collected by systematic assessment
[1]
grade 3 epigastric pain
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Morphine Intrathecal Pump
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      0/0    
Gastrointestinal disorders     
reflux intermittent [1]  1/1 (100.00%)  1 0/0  0
General disorders     
fatigue [1]  1/1 (100.00%)  1 0/0  0
[1]
grade 1
Subject started study 7/14/2010, but withdrew her consent on 7/24/2010 due to increased upper quadrant pain. One subject enrolled. She withdrew consent before study team could collect any follow-up data. We do not have any participants to analyze.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Erdek, MD
Organization: Sidney Kimmel Comprehensive Cancer Center
Phone: 410-502-7388
EMail: merdek1@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00660348    
Other Study ID Numbers: JHOC-J0724 CDR0000593173
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0724
JHOC_NA_00009208
First Submitted: April 16, 2008
First Posted: April 17, 2008
Results First Submitted: May 21, 2014
Results First Posted: October 8, 2014
Last Update Posted: October 8, 2014