Acupuncture And Acupressure In Treating Patients With Moderate Or Severe Pain Related To Stage III Or Stage IV Pancreatic Cancer

Study Overview

Acupuncture and Acupressure in Treating Patients With Moderate or Severe Pain Related to Stage III or Stage IV Pancreatic Cancer

RATIONALE: Acupuncture and acupressure may help relieve moderate or severe pain associated with stage III or stage IV pancreatic cancer. PURPOSE: Phase II trial to study the effectiveness of acupuncture and accupressure in treating patients who have moderate or severe pain associated with stage III or stage IV pancreatic cancer.

OBJECTIVES: * Assess the effects of acupuncture and acupressure on pain, sedation, and use of opiate medication in patients with moderate or severe pain related to stage III or IV pancreatic cancer. * Determine whether controlled trials of this therapy are warranted in this patient population. * Provide data to aid design of further warranted studies of this therapy in this patient population. OUTLINE: Patients receive acupuncture treatment comprising 20 minutes of needle insertion into the arms and abdomen to the depth used in traditional Chinese medicine on approximately days 4, 7, 11, and 14. After each acupuncture treatment, the acupuncturist applies/reapplies acupressure devices by inserting 2-6 smaller needles (studs) into the abdomen (which are held in place with surgical tape) and taping tiny metal balls to 3 points in each ear. Patients or caregivers are instructed to administer acupressure by pressing on the ear points (metal balls) for 1-2 minutes per point and moving the semi-permanent abdominal needles in small circular movements with the fingers, at a rate of 2-3 cycles per second, for 1-2 minutes per point, upon waking in the morning and in the early afternoon. Patients or caregivers are also instructed to stimulate a "rescue point" (the Shenmen auricular point) if patients experience pain exacerbations at other times during the day. Patients who respond well to acupuncture are offered further treatment. Pain is assessed using the numerical rating scale on approximately days 1-4, 7, 11, and 14-17. Sedation is assessed using the Profile of Mood States (POMS) on approximately days 3 and 17. Analgesic medication use is assessed on approximately days 1-3 and 15-17. PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within approximately 2 years.

Pain
Pancreatic Cancer

PROCEDURE: complementary or alternative medicine procedure
PROCEDURE: pain therapy

02-008
CDR0000069411 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))
NCI-G02-2082

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2002-07-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-06-04
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-06-05
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2013-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Diagnosis of stage III or IV primary pancreatic cancer
At least 4 days since prior change in type of pain medication
No change in dose of long-acting analgesics
Actual dose of as needed (PRN) pain medication may vary
One of the following pain scores:

Pain score of at least 4 on a scale of 0 to 10
A score of at least 54 out of 88 on the combined relevant Profile of Mood States (POMS) subscales (Vigor, Fatigue, and Confusion) with no evidence that sedation results from cause other than opiate medication and patient reported using PRN opiates on at least 4 of the past 7 days (patients who are eligible for this study on the basis of POMS scores must be taking PRN medication)

Over 18

Not specified

At least 4 weeks

Absolute neutrophil count at least 500/mm^3
Platelet count at least 20,000/mm^3

INR no greater than 2.5

Not specified

No heart valve dysfunction

No uncontrolled infection

Not specified

At least 4 weeks since prior gemcitabine unless there is documented disease progression
Concurrent chemotherapy (except gemcitabine) allowed

Not specified

At least 3 weeks since prior radiotherapy
No concurrent radiotherapy

At least 1 week since prior epidural analgesia, celiac plexus block, or thoracoscopic or open splanchnicectomy
No concurrent epidural analgesia, celiac plexus block, or thoracoscopic or open splanchnicectomy

See Disease Characteristics
At least 3 months since prior acupuncture
Concurrent experimental treatments allowed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Barrie R. Cassileth, PhD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record