Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136669
Status:
COMPLETED
Last Update Posted:
2006-09-08
First Post:
2005-08-25
Brief Title:
Acupuncture For Pancreatic Cancer Pain
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Acupuncture For Pancreatic Cancer Pain A Randomized Phase III Study
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pain is a common problem in patients with pancreatic cancer Some patients suffer from pain despite medication We the researchers at Memorial Sloan-Kettering Cancer Center are conducting a Phase III study to determine the effects of acupuncture on pain in patients with pancreatic cancer The purpose of a Phase III study is to determine whether or not a treatment is helpful This study will include about 60 patients
Acupuncture is the insertion of very fine needles into the skin to treat symptoms In recent years researchers have found evidence that acupuncture is useful in treating a variety of conditions including headache nausea and pain
Acupuncture is the insertion of very fine needles into the skin to treat symptoms In recent years researchers have found evidence that acupuncture is useful in treating a variety of conditions including headache nausea and pain
Detailed Description:
The main aim of this pancreatic cancer pain trial is to determine the effects of a single practitioner-given acupuncture treatment followed by semi-permanent acupuncture studs Our primary endpoint is subjective therefore a placebo control will be applied with patients blinded to treatment allocation
In clinical practice acupuncturists individualize treatment two patients with a similar conventional diagnosis may receive different point prescriptions depending on the acupuncture differential diagnosis Randomized trials of acupuncture can either prescribe a fixed treatment formula in terms of the number of sessions and points to be used or allow practitioners to exercise clinical judgment in individualizing care There has been considerable debate in the methodological literature about the merits of each approach The use of a fixed treatment schedule increases the reproducibility of the findings but is said by practitioners to generally reduce treatment effectiveness In this trial we have developed an approach that allows practitioners to individualize treatments in a manner that allows exact replication by specifying particular point locations to be used depending on the sites where a patient experiences pain Point locations for this and for all of our acupuncture studies are determined by our licensed credentialled acupuncturists
Following accrual of the initial 10-15 patients we will review treatment compliance blinding and accrual Adjustments will be made to deal with compliance issues to facilitate placebo blinding or deal with recruitment problems for the remainder of the study
In clinical practice acupuncturists individualize treatment two patients with a similar conventional diagnosis may receive different point prescriptions depending on the acupuncture differential diagnosis Randomized trials of acupuncture can either prescribe a fixed treatment formula in terms of the number of sessions and points to be used or allow practitioners to exercise clinical judgment in individualizing care There has been considerable debate in the methodological literature about the merits of each approach The use of a fixed treatment schedule increases the reproducibility of the findings but is said by practitioners to generally reduce treatment effectiveness In this trial we have developed an approach that allows practitioners to individualize treatments in a manner that allows exact replication by specifying particular point locations to be used depending on the sites where a patient experiences pain Point locations for this and for all of our acupuncture studies are determined by our licensed credentialled acupuncturists
Following accrual of the initial 10-15 patients we will review treatment compliance blinding and accrual Adjustments will be made to deal with compliance issues to facilitate placebo blinding or deal with recruitment problems for the remainder of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None