NCT00136669

Brief Summary

Pain is a common problem in patients with pancreatic cancer. Some patients suffer from pain despite medication. We, the researchers at Memorial Sloan-Kettering Cancer Center, are conducting a Phase III study to determine the effects of acupuncture on pain in patients with pancreatic cancer. The purpose of a Phase III study is to determine whether or not a treatment is helpful. This study will include about 60 patients. Acupuncture is the insertion of very fine needles into the skin to treat symptoms. In recent years, researchers have found evidence that acupuncture is useful in treating a variety of conditions, including headache, nausea, and pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

September 8, 2006

Status Verified

September 1, 2006

First QC Date

August 25, 2005

Last Update Submit

September 7, 2006

Conditions

Keywords

AcupuncturePainPancreatic Neoplasms

Outcome Measures

Primary Outcomes (2)

  • To determine whether acupuncture reduces pain in pancreatic cancer patients more effectively than placebo

  • To determine the duration of acupuncture effects

Interventions

AcupuncturePROCEDURE

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of pancreatic adenocarcinoma.
  • First baseline current pain score of 3 or above on a 0 - 10 numerical rating scale.
  • In the opinion of the treating physician or a medically qualified investigator, the patient's pain syndrome is the result of underlying cancer.
  • Patient OR caregiver must be willing and able to apply pressure to each point using small circular movements with the fingers twice per day.

You may not qualify if:

  • Primary cause of pain is procedural (e.g. postoperative pain).
  • Acupuncture treatment in the past six weeks. Patients should not receive acupuncture during the one week period of the study.
  • Neutropenia defined as absolute neutrophil count (ANC) \<1000/microliter.
  • Cardiac conditions constituting high or moderate risk of endocarditis as defined by the American Heart Association criteria.
  • Patient contraindicated for phlebotomy, as phlebotomy needles are much larger than acupuncture needles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsPain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Barrie R. Cassileth, Ph.D.

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

September 1, 2003

Study Completion

September 1, 2005

Last Updated

September 8, 2006

Record last verified: 2006-09

Locations