Trial Outcomes & Findings for Standard Pain Control or Intrathecal Therapy in Controlling Pain in Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer (NCT NCT00660348)

Last Updated: 2014-10-08

Results Overview

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.).

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

1 month

Results posted on

2014-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Morphine morphine given traditionally (IV, pill, patch) morphine sulfate: This is morphine given in the traditional methods.	Intrathecal Pump 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.
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Morphine morphine given traditionally (IV, pill, patch) morphine sulfate: This is morphine given in the traditional methods.	Intrathecal Pump 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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1 month

Population: 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.

Outcome measures

Outcome data not reported

Adverse Events

Morphine

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Intrathecal Pump

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Morphine n=1 participants at risk morphine given traditionally (IV, pill, patch) morphine sulfate: This is morphine given in the traditional methods.	Intrathecal Pump 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.
Gastrointestinal disorders epigastric pain (upper quadrant)	100.0% 1/1 • Number of events 1	— 0/0

Other adverse events

Other adverse events
Measure	Morphine n=1 participants at risk morphine given traditionally (IV, pill, patch) morphine sulfate: This is morphine given in the traditional methods.	Intrathecal Pump 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.
Gastrointestinal disorders reflux intermittent	100.0% 1/1 • Number of events 1	— 0/0
General disorders fatigue	100.0% 1/1 • Number of events 1	— 0/0

Additional Information

Michael Erdek, MD

Sidney Kimmel Comprehensive Cancer Center

Phone: 410-502-7388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Morphine n=1 Participants morphine given traditionally (IV, pill, patch) morphine sulfate: This is morphine given in the traditional methods.	Intrathecal Pump 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 n=1 Participants Total of all reporting groups
Age, Continuous	55 years n=5 Participants	—	55 years n=5 Participants
Age, Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 participants n=5 Participants	—	1 participants n=5 Participants
Age, Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Gender Female	1 participants n=5 Participants	—	1 participants n=5 Participants
Gender Male	0 participants n=5 Participants	—	0 participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 participants n=5 Participants	—	0 participants n=5 Participants
Race (NIH/OMB) Asian	0 participants n=5 Participants	—	0 participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	—	0 participants n=5 Participants
Race (NIH/OMB) Black or African American	0 participants n=5 Participants	—	0 participants n=5 Participants
Race (NIH/OMB) White	1 participants n=5 Participants	—	1 participants n=5 Participants
Race (NIH/OMB) More than one race	0 participants n=5 Participants	—	0 participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 participants n=5 Participants	—	0 participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 participants n=5 Participants	—	0 participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 participants n=5 Participants	—	1 participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 participants n=5 Participants	—	0 participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants