Usefulness of Acupuncture in Cancer Pain and Quality of Life

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sivarama Vinjamury, Southern California University of Health Sciences
ClinicalTrials.gov Identifier:
NCT00401063
First received: November 15, 2006
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to assess the effects of acupuncture on aspects of health including pain, energy level, sleep quality, activities of daily living and appetite.


Condition Intervention
Cancer
Pain
Device: Acupuncture

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acupuncture Case Series: Cancer Pain and Quality of Life

Resource links provided by NLM:


Further study details as provided by Southern California University of Health Sciences:

Primary Outcome Measures:
  • EORTC QLQ-30 Quality of Life Questionnaire for Cancer Patients [ Time Frame: Every two weeks, 0, 2, 4, 6, 8 and 12 ] [ Designated as safety issue: No ]
  • Visual Analogue Scale [ Time Frame: Every two weeks, 0,2,4,6,8, and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BDI Psychological Assessment [ Time Frame: Every two weeks, 0, 2, 4, 6, 8 and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: September 2006
Study Completion Date: October 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm
Acupuncture treatment
Device: Acupuncture
Acupuncture treatment twice a day for eight weeks

Detailed Description:

After receiving permission from the attending physician each study participant who meets the inclusion criteria will then undergo a physical examination and fill out several questionnaires. Each participant will undergo one to three treatments per week for a period of eight weeks. There will be one follow-up visit on the twelfth week. Participation in this study is free of charge, including all exams, treatment and informational material.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of cancer by an MD/oncologist
  • Age of 18 or older
  • Baseline pain score of 3 or above on 0-10 rating scale
  • In the evaluation of the treating physician or medically-qualified investigator, the patient's pain syndrome is the result of underlying cancer or cancer treatment
  • Being ambulatory
  • Permission from the treating physician (MD/oncologist)
  • Platelet count of 50,000 or greater

Exclusion Criteria:

  • Acupuncture treatment in past four weeks
  • Neutropenia defined as ANC (absolute neutrophil count) < 1000/ml
  • Inability to obtain permission from the treating physician
  • Unwillingness to sign informed consent form
  • Involvement in litigation
  • Simultaneous infection with HIV or Hepatitis C virus
  • Unable to present for follow up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401063

Locations
United States, California
University Health Center
Pasadena, California, United States, 91104
Southern California University of Health Sciences
Whittier, California, United States, 90604
Sponsors and Collaborators
Southern California University of Health Sciences
Investigators
Principal Investigator: Sivarama P Vinjamury, MD, MAOM Southern California University of Health Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Sivarama Vinjamury, Professor, Southern California University of Health Sciences
ClinicalTrials.gov Identifier: NCT00401063     History of Changes
Other Study ID Numbers: SCU-06-VINJ001
Study First Received: November 15, 2006
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California University of Health Sciences:
Cancer
Acupuncture
Cancer Pain
Quality of life

ClinicalTrials.gov processed this record on August 28, 2014