NCT00401063

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Sep 2006

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

2 active sites

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, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

11 months

First QC Date

November 15, 2006

Last Update Submit

May 28, 2013

Conditions

Keywords

CancerAcupunctureCancer PainQuality of life

Outcome Measures

Primary Outcomes (2)

  • EORTC QLQ-30 Quality of Life Questionnaire for Cancer Patients

    Every two weeks, 0, 2, 4, 6, 8 and 12

  • Visual Analogue Scale

    Every two weeks, 0,2,4,6,8, and 12 weeks

Secondary Outcomes (1)

  • BDI Psychological Assessment

    Every two weeks, 0, 2, 4, 6, 8 and 12 weeks

Study Arms (1)

Single arm

OTHER

Acupuncture treatment

Device: Acupuncture

Interventions

Acupuncture treatment twice a day for eight weeks

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Health Center

Pasadena, California, 91104, United States

Location

Southern California University of Health Sciences

Whittier, California, 90604, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsPainCancer Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Sivarama P Vinjamury, MD, MAOM

    Southern California University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 17, 2006

Study Start

September 1, 2006

Primary Completion

August 1, 2007

Study Completion

October 1, 2007

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations