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PainPhase 2NCT00040833

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

A Phase 2 study testing complementary or alternative medicine procedure and pain therapy in people with Pain and Pancreatic Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Pancreatic Cancer
What is being tested?
complementary or alternative medicine procedure and pain therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
1 siteUnited States
Study dates
Feb 2002to Jun 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
complementary or alternative medicine procedure, pain therapy
Keywords
stage III pancreatic cancer, recurrent pancreatic cancer, pain, stage IV pancreatic cancer
Medical subject headings
Pain, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • complementary or alternative medicine procedureProcedure or surgery

  • pain therapyProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2002
  3. Primary completionJun 2003
  4. Study completionJun 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
IDs, dates and publications
ClinicalTrials.gov ID
NCT00040833
Sponsor's protocol ID
02-008
Other IDs
CDR0000069411, NCI-G02-2082
Status last verified
Jun 2013
First submitted
8 Jul 2002
Last updated
5 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing complementary or alternative medicine procedure and pain therapy in people with Pain and Pancreatic Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00040833.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.

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