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Acupuncture for the Treatment of Pancreatic Cancer Pain: A Single Arm Phase II Study


Phase 2
18 Years
N/A
Not Enrolling
Both
Pain, Pancreatic Cancer

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Trial Information

Acupuncture for the Treatment of Pancreatic Cancer Pain: A Single Arm Phase II Study


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Barrie R. Cassileth, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

02-008

NCT ID:

NCT00040833

Start Date:

February 2002

Completion Date:

June 2003

Related Keywords:

  • Pain
  • Pancreatic Cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • pain
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021