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.
Procedure: complementary or alternative medicine procedure
Procedure: pain therapy
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||Acupuncture for the Treatment of Pancreatic Cancer Pain: A Single Arm Phase II Study|
|Study Start Date:||February 2002|
|Study Completion Date:||June 2003|
|Primary Completion Date:||June 2003 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040833
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Barrie R. Cassileth, PhD||Memorial Sloan Kettering Cancer Center.|