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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00040833
First received: July 8, 2002
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Pain
Pancreatic Cancer
Procedure: complementary or alternative medicine procedure
Procedure: pain therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: Acupuncture for the Treatment of Pancreatic Cancer Pain: A Single Arm Phase II Study

Resource links provided by NLM:


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

Study Start Date: February 2002
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Not specified

Life expectancy:

  • At least 4 weeks

Hematopoietic:

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

Hepatic:

  • INR no greater than 2.5

Renal:

  • Not specified

Cardiovascular:

  • No heart valve dysfunction

Other:

  • No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • 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

Other:

  • See Disease Characteristics
  • At least 3 months since prior acupuncture
  • Concurrent experimental treatments allowed
  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: NCT00040833

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
Study Chair: Barrie R. Cassileth, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00040833     History of Changes
Other Study ID Numbers: 02-008, CDR0000069411, NCI-G02-2082
Study First Received: July 8, 2002
Last Updated: June 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage III pancreatic cancer
recurrent pancreatic cancer
pain
stage IV pancreatic cancer

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

ClinicalTrials.gov processed this record on July 23, 2014