Acupuncture For Pancreatic Cancer Pain: A Randomized Phase III Study
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
To determine whether acupuncture reduces pain in pancreatic cancer patients more effectively than placebo
Barrie R. Cassileth, Ph.D.
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
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