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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00957112
First received: August 11, 2009
Last updated: August 23, 2013
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Anxiety Disorder
Breast Cancer
Depression
Fatigue
Procedure: acupuncture therapy
Procedure: standard follow-up care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Efficacy of Acupuncture and Self-acupuncture in Managing Cancer-related Fatigue in Breast Cancer Patients: a Pragmatic Randomised Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • General fatigue as measured by the Multidimensional Fatigue Inventory [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mental fatigue as measured by the Multidimensional Fatigue Inventory [ Designated as safety issue: No ]
  • Anxiety as measured by the Hospital Anxiety and Depression Scale [ Designated as safety issue: No ]
  • Depression as measured by the Hospital Anxiety and Depression Scale [ Designated as safety issue: No ]
  • Quality of life as measured by the FACT-G and Breast Cancer module [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: October 2007
Study Completion Date: February 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957112

Locations
United Kingdom
University of Manchester
Manchester, England, United Kingdom, M13 9PL
Sponsors and Collaborators
University of Manchester
Investigators
Principal Investigator: Alex Molassiotis, MD University of Manchester
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00957112     History of Changes
Other Study ID Numbers: CDR0000649750, UM-ASA, EU-20970
Study First Received: August 11, 2009
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
anxiety disorder
depression
fatigue
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Fatigue
Depression
Depressive Disorder
Anxiety Disorders
Breast Neoplasms
Signs and Symptoms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014