NCT00177840

Brief Summary

This study will evaluate if acupuncture is helpful in treating cancer-related fatigue in breast cancer patients undergoing radiation therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2005

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

1.8 years

First QC Date

September 13, 2005

Last Update Submit

March 27, 2008

Conditions

Fatigue

Keywords

cancer-related fatigueacupuncturebreast cancer

Outcome Measures

Primary Outcomes (1)

  • Cancer-related fatigue

    10 weeks

Secondary Outcomes (2)

  • Cancer-related fatigue distress

    10 weeks

  • Quality of life

    10 weeks

Study Arms (2)

1

EXPERIMENTAL

True acupuncture using true needles

Procedure: acupuncture

2

SHAM COMPARATOR

sham acupuncture using sham needles

Procedure: acupuncture

Interventions

acupuncturePROCEDURE
12

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Localized breast cancer
  • Average to above average fatigue
  • Planning radiation therapy

You may not qualify if:

  • History of acupuncture treatment
  • Allergy to stainless steel
  • Pacemaker
  • Anticoagulant therapy
  • Known bleeding disorder
  • Metastatic breast cancer
  • Seizure disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

FatigueBreast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Judith Balk, MD MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Primary Completion

July 1, 2007

Study Completion

September 1, 2007

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations

US(1)