Acupuncture For Pancreatic Cancer Pain

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00136669
First received: August 25, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Pancreatic Neoplasms
Pain
Procedure: Acupuncture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Acupuncture For Pancreatic Cancer Pain: A Randomized Phase III Study

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine whether acupuncture reduces pain in pancreatic cancer patients more effectively than placebo
  • To determine the duration of acupuncture effects

Estimated Enrollment: 60
Study Start Date: September 2003
Estimated Study Completion Date: September 2005
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of pancreatic adenocarcinoma.
  • First baseline current pain score of 3 or above on a 0 – 10 numerical rating scale.
  • In the opinion of the treating physician or a medically qualified investigator, the patient’s pain syndrome is the result of underlying cancer.
  • Patient OR caregiver must be willing and able to apply pressure to each point using small circular movements with the fingers twice per day.

Exclusion Criteria:

  • Primary cause of pain is procedural (e.g. postoperative pain).
  • Acupuncture treatment in the past six weeks. Patients should not receive acupuncture during the one week period of the study.
  • Neutropenia defined as absolute neutrophil count (ANC) <1000/microliter.
  • Cardiac conditions constituting high or moderate risk of endocarditis as defined by the American Heart Association criteria.
  • Patient contraindicated for phlebotomy, as phlebotomy needles are much larger than acupuncture needles.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136669

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Barrie R. Cassileth, Ph.D. Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00136669     History of Changes
Other Study ID Numbers: 03-106
Study First Received: August 25, 2005
Last Updated: September 7, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Acupuncture
Pain
Pancreatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014