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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
General fatigue as measured by the Multidimensional Fatigue Inventory
Alex Molassiotis, MD
University of Manchester