Acupuncture or Self-Acupuncture in Managing Cancer-Related Fatigue in Women Who Have Received Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer

August 23, 2013 updated by: University of Manchester

The Efficacy of Acupuncture and Self-acupuncture in Managing Cancer-related Fatigue in Breast Cancer Patients: a Pragmatic Randomised Trial

RATIONALE: Acupuncture may help relieve fatigue caused by breast cancer. It is not yet known whether acupuncture is more effective than self-acupuncture in managing fatigue in women with breast cancer.

PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared with self-acupuncture in managing cancer-related fatigue in women who have received chemotherapy for stage I, stage II, or stage IIIA breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Assess the efficacy of a course of acupuncture in the management of cancer-related fatigue in a homogeneous sample of women with stage I, II, or IIIA breast cancer who have completed adjuvant chemotherapy.
  • Assess the efficacy of self-acupuncture in comparison to therapist-administered acupuncture in sustaining, in the longer term, any effects observed with a 6-week course of acupuncture in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to study center and fatigue score (low vs moderate vs severe). Patients are randomized at 3:1 ratio (arm I: arm II) to 1 of 2 treatment arms.

  • Arm I (experimental): Patients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management.
  • Arm II (control): Patients undergo standard care. They also receive written information about fatigue as in arm I.

After 6 weeks, patients in arm I are again randomized to 1 of 3 arms.

  • Arm A: Patients receive treatment as in arm I for 4 more weeks.
  • Arm B: Patients receive treatment as in arm II for 4 more weeks.
  • Arm C: Patients learn to self-acupuncture and do so weekly for 4 more weeks. All patients complete questionnaires on fatigue, hospital anxiety and depression, quality of life, and use of complementary therapies at baseline and periodically during study. Patient's sociodemographic and treatment characteristic records are also reviewed.

After completion of study therapy, patients are followed up periodically for 18 weeks.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 3

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 Kingdom
    • England
      • Manchester, England, United Kingdom, M13 9PL
        • University of Manchester

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer

    • Stage I, II, or IIIA disease

  • Completed prior chemotherapy for ≥ 1 month and up to 5 years

    • No needling on the ipsilateral arm of patients who have undergone axillary dissection
    • No needling on the lymphedematous limbs
  • Score of ≥ 5 on a 0-10 single-item screening fatigue scale, where 0 is no fatigue at all and 10 is extremely fatigued
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 6 months
  • Menopausal status not specified
  • Platelet count ≥ 50,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Hematocrit ≥ 30%
  • Not pregnant
  • No needle phobia

  • No co-morbidity with any of the following:

    • Bleeding disorder
    • Thyroid dysfunction

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No planned concurrent chemoradiotherapy
  • No concurrent steroids
  • No concurrent epoetin alfa or transfusion for anemia
  • No other concurrent complementary therapies

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: Supportive Care
  • Allocation: Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management.
Procedure: acupuncture therapy
Patients undergo therapist-acupuncture with or without self-acupuncture
No Intervention: Arm II
Patients receive standard care. They also receive written information about fatigue as in arm I.
Procedure: standard follow-up care
Patients receive standard care
Experimental: Arm A
Patients receive treatment as in arm I for 4 more weeks.
Procedure: acupuncture therapy
Patients undergo therapist-acupuncture with or without self-acupuncture
No Intervention: Arm B
Patients receive standard care as in arm II for 4 more weeks.
Procedure: standard follow-up care
Patients receive standard care
Experimental: Arm C
Patients learn to self-acupuncture and do so weekly for 4 more weeks.
Procedure: acupuncture therapy
Patients undergo therapist-acupuncture with or without self-acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
General fatigue as measured by the Multidimensional Fatigue Inventory

Secondary Outcome Measures

Outcome Measure
Mental fatigue as measured by the Multidimensional Fatigue Inventory
Anxiety as measured by the Hospital Anxiety and Depression Scale
Depression as measured by the Hospital Anxiety and Depression Scale
Quality of life as measured by the FACT-G and Breast Cancer module

Collaborators and Investigators

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

Sponsor

University of Manchester

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.

General Publications

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

October 1, 2007

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (Estimate)

August 12, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000649750
  • UM-ASA
  • EU-20970

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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