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

Phase 3
Open (Enrolling)
Anxiety Disorder, Breast Cancer, Depression, Fatigue

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Trial Information

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


- 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

- 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.

Inclusion Criteria


- 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

- 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


- 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


- See Disease Characteristics

- No planned concurrent chemoradiotherapy

- No concurrent steroids

- No concurrent epoetin alfa or transfusion for anemia

- No other concurrent complementary therapies

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

General fatigue as measured by the Multidimensional Fatigue Inventory

Safety Issue:


Principal Investigator

Alex Molassiotis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Manchester



Study ID:




Start Date:

October 2007

Completion Date:

Related Keywords:

  • Anxiety Disorder
  • Breast Cancer
  • Depression
  • Fatigue
  • anxiety disorder
  • depression
  • fatigue
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Anxiety Disorders
  • Breast Neoplasms
  • Depression
  • Depressive Disorder
  • Fatigue