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

University of Manchester

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Anxiety Disorder; Depression; Fatigue

Treatments: Procedure: standard follow-up care; Procedure: acupuncture therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00957112

UM-ASA

CDR0000649750

EU-20970

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

320 participants in 5 patient groups

Arm I

Experimental group

Description:

Patients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management.

Treatment:

Procedure: acupuncture therapy

Arm II

No Intervention group

Description:

Patients receive standard care. They also receive written information about fatigue as in arm I.

Treatment:

Procedure: standard follow-up care

Arm A

Experimental group

Description:

Patients receive treatment as in arm I for 4 more weeks.

Treatment:

Procedure: acupuncture therapy

Arm B

No Intervention group

Description:

Patients receive standard care as in arm II for 4 more weeks.

Treatment:

Procedure: standard follow-up care

Arm C

Experimental group

Description:

Patients learn to self-acupuncture and do so weekly for 4 more weeks.

Treatment:

Procedure: acupuncture therapy