Usefulness of Acupuncture in Cancer Pain and Quality of Life

May 28, 2013 updated by: Sivarama Vinjamury, Southern California University of Health Sciences

Acupuncture Case Series: Cancer Pain and Quality of Life

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91104
        • University Health Center
      • Whittier, California, United States, 90604
        • Southern California University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm
Acupuncture treatment
Device: Acupuncture
Acupuncture treatment twice a day for eight weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EORTC QLQ-30 Quality of Life Questionnaire for Cancer Patients
Time Frame: Every two weeks, 0, 2, 4, 6, 8 and 12
Every two weeks, 0, 2, 4, 6, 8 and 12
Visual Analogue Scale
Time Frame: Every two weeks, 0,2,4,6,8, and 12 weeks
Every two weeks, 0,2,4,6,8, and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
BDI Psychological Assessment
Time Frame: Every two weeks, 0, 2, 4, 6, 8 and 12 weeks
Every two weeks, 0, 2, 4, 6, 8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California University of Health Sciences

Investigators

  • Principal Investigator: Sivarama P Vinjamury, MD, MAOM, Southern California University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

November 15, 2006

First Submitted That Met QC Criteria

November 15, 2006

First Posted (Estimate)

November 17, 2006

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 28, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCU-06-VINJ001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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