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Acupuncture For Pancreatic Cancer Pain

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ClinicalTrials.gov Identifier: NCT00136669
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : September 8, 2006
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Pain Procedure: Acupuncture Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Acupuncture For Pancreatic Cancer Pain: A Randomized Phase III Study
Study Start Date : September 2003
Estimated Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00136669     History of Changes
Other Study ID Numbers: 03-106
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: September 2006

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Cancer Pain
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms