The Efficacy of Acupuncture and Self-acupuncture in Managing Cancer-related Fatigue in Breast Cancer Patients: a Pragmatic Randomised Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- General fatigue as measured by the Multidimensional Fatigue Inventory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: acupuncture therapy (Procedure)
Arm II
Patients receive standard care. They also receive written information about fatigue as in arm I.
干预措施: standard follow-up care (Procedure)
Arm A
Patients receive treatment as in arm I for 4 more weeks.
干预措施: acupuncture therapy (Procedure)
Arm B
Patients receive standard care as in arm II for 4 more weeks.
干预措施: standard follow-up care (Procedure)
Arm C
Patients learn to self-acupuncture and do so weekly for 4 more weeks.
干预措施: acupuncture therapy (Procedure)
结局指标
主要结局
General fatigue as measured by the Multidimensional Fatigue Inventory
次要结局
- 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