MedDataX Logo

Acupuncture to Treat Cancer-Related Fatigue in Breast Cancer Patients

NCT ID: NCT00177840

Last Updated: 2008-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Each participant will have a baseline visit before her radiation therapy begins to complete questionnaires. Participants will receive either true acupuncture or sham acupuncture twice per week for the six weeks of radiation therapy. She will have a short questionnaire at three weeks into her radiation, and she will complete questionnaires again at the end of her radiation and four weeks later.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fatigue

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

cancer-related fatigue acupuncture breast cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

True acupuncture using true needles

Group Type EXPERIMENTAL

acupuncture

Intervention Type PROCEDURE

2

sham acupuncture using sham needles

Group Type SHAM_COMPARATOR

acupuncture

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

acupuncture

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* History of acupuncture treatment
* Allergy to stainless steel
* Pacemaker
* Anticoagulant therapy
* Known bleeding disorder
* Metastatic breast cancer
* Seizure disorder
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Pittsburgh

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Judith Balk, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R21CA098659-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0506139

Identifier Type: -

Identifier Source: org_study_id