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

NCT ID: NCT00040833

Last Updated: 2013-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2003-06-30

Brief Summary

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.

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.

Conditions

Pain; Pancreatic Cancer

Study Design

• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

complementary or alternative medicine procedure

Intervention Type: PROCEDURE

pain therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Barrie R. Cassileth, PhD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000069411

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G02-2082

Identifier Type: -

Identifier Source: secondary_id

02-008

Identifier Type: -

Identifier Source: org_study_id