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Usefulness of Acupuncture in Cancer Pain and Quality of Life

Primary Purpose

Cancer, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Southern California University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cancer, Acupuncture, Cancer Pain, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Center
  • Southern California University of Health Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

Acupuncture treatment

Outcomes

Primary Outcome Measures

EORTC QLQ-30 Quality of Life Questionnaire for Cancer Patients
Visual Analogue Scale

Secondary Outcome Measures

BDI Psychological Assessment

Full Information

First Posted
November 15, 2006
Last Updated
May 28, 2013
Sponsor
Southern California University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00401063
Brief Title
Usefulness of Acupuncture in Cancer Pain and Quality of Life
Official Title
Acupuncture Case Series: Cancer Pain and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern California University of Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pain
Keywords
Cancer, Acupuncture, Cancer Pain, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
Acupuncture treatment
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture treatment twice a day for eight weeks
Primary Outcome Measure Information:
Title
EORTC QLQ-30 Quality of Life Questionnaire for Cancer Patients
Time Frame
Every two weeks, 0, 2, 4, 6, 8 and 12
Title
Visual Analogue Scale
Time Frame
Every two weeks, 0,2,4,6,8, and 12 weeks
Secondary Outcome Measure Information:
Title
BDI Psychological Assessment
Time Frame
Every two weeks, 0, 2, 4, 6, 8 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sivarama P Vinjamury, MD, MAOM
Organizational Affiliation
Southern California University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Center
City
Pasadena
State/Province
California
ZIP/Postal Code
91104
Country
United States
Facility Name
Southern California University of Health Sciences
City
Whittier
State/Province
California
ZIP/Postal Code
90604
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.scuhs.edu
Description
Visit Southern California University of Health Sciences Website

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Usefulness of Acupuncture in Cancer Pain and Quality of Life

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