Full Text View
Tabular View
No Study Results Posted
Related Studies
Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2009
First Received: June 15, 2007   Last Updated: September 15, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00487331
  Purpose

The goal of this clinical research study is to learn if using acupuncture with or without electrical stimulation in cancer patients with high levels of pain can help to relieve the pain.


Condition Intervention
Solid Tumors
Pain
Other: Acupuncture
Behavioral: Survey

Study Type: Interventional
Study Design: Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Acupuncture for Treatment of Uncontrolled Pain: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patients' Reported Satisfaction with Acupuncture Services [ Time Frame: Derived from surveys completed by participating patients over 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: June 2007
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Acupuncture: Experimental Other: Acupuncture
Acupuncture sessions 1-3 times per week.
Behavioral: Survey
2 pain questionnaires + satisfaction survey completed at beginning and end of treatment

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients, or the legal guardians of patients must have the ability to understand English, sign a written informed consent, and be willing to follow protocol requirements.
  2. ECOG Performance Status of 0, 1, or 2.
  3. Pain score >/= 4 on the on a 0-10 NRS pain scale after all efforts have been attempted in the PMC to control pain.

Exclusion Criteria:

  1. Local infection at or near the acupuncture site. (Although acupuncture is a minimally invasive procedure, patients will be excluded if there is an indication of infection.)
  2. Deformities that could interfere with accurate acupuncture point location.
  3. Known coagulopathy and taking any dose of warfarin (i.e., Coumadin) or heparin, including low molecular weight heparin (i.e., Lovenox). Patients may participate if they are taking Plavix, aspirin or other non-steroidal anti-inflammatory agents.
  4. Mental incapacitation or significant emotional or psychological disorder that, in the opinion of the investigators, precludes study entry as these patients may not be able to cooperative with this slightly invasive procedure or with the data collection process.
  5. Labs: platelets <100,000 and/or WBC < 3000 on most recent report. (Note: Whether or not lab work is drawn prior to beginning the acupuncture treatment will be left to the discretion of the referring physician. Patients with platelets <100,000 may participate with written approval from the attending physician.)
  6. Planned changes in the pain medication regimen.
  7. Women who are pregnant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487331

Contacts
Contact: Larry C. Driver, MD 713-745-7246

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Larry C. Driver, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Larry C. Driver, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Larry C. Driver, MD/Professor )
Study ID Numbers: 2006-1113
Study First Received: June 15, 2007
Last Updated: September 15, 2009
ClinicalTrials.gov Identifier: NCT00487331     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Solid Tumors
Acupuncture
Uncontrolled Pain
Pain

ClinicalTrials.gov processed this record on February 08, 2010