NCT00658034Unknown3 期
Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: a Randomized Phase III Trial
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
研究概览
简要总结
This is a randomized, placebo controlled study in cancer patients reporting fatigue persisting for at least two months following completion of chemotherapy. Subjects will receive 6 weeks of either acupuncture or placebo treatment as a means of evaluating whether acupuncture reduces chronic fatigue after chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18-64 diagnosed with a malignancy (solid tumor or hematologic malignancy).
- •Patients must have received chemotherapy.
- •Patients must complain of fatigue following chemotherapy buy not prior to chemotherapy.
- •At least 60 days must have elapsed between the last chemotherapy infusion and completion of the first baseline questionnaire.
- •Mean baseline fatigue as measured by the Brief Fatigue Inventory must be four or above.
排除标准
- •Anemia, defined as Hb<9 or active treatment for anemia. Iron supplementation is allowed as long as the dose has been stable for at least six weeks.
- •Platelets less than 50,000/microliter or an Absolute Neutrophil Count less than 1,000/microliter.
- •Baseline depression score on the Hospital Anxiety and Depression Scale of 11 or above, indicating clinical depression.
- •Thyroid disorder, defined as either thyroid stimulating hormone or free T4 out of normal range, is excluded as it is a possible cause of fatigue unrelated to cancer therapy.
- •Surgery under general anesthesia; immunotherapy; radiotherapy; or initiation of hormonal therapy within the three weeks prior to enrollment.
- •Acupuncture in the previous six weeks.
- •Change in use of any of the following drugs in the prior three weeks: opiates, antidepressants (other than selective serotonin reuptake inhibitors [SSRIs])/anxiolytics; OR change in use of SSRIs in the prior six weeks. "Change in use" is defined as initiation or cessation of treatment, or change in prescribed dose or regimen: changes in actual amounts of PRN medication taken are allowed.
结局指标
主要结局
To determine whether acupuncture reduces chronic fatigue after chemotherapy more effectively than placebo
时间窗: six weeks
次要结局
- To examine the long term effects of acupuncture treatment on fatigue(six months)
- To examine predictors of response to acupuncture treatment in terms of baseline symptoms, hemoglobin, age, sex, time since chemotherapy, and concurrent treatment(six months)
- To examine the effect of acupuncture on levels of physical activity and quality of life(six months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Acupuncture for the Treatment of Chronic Post-Chemotherapy Fatigue: A Randomized, Phase III TrialCancerNCT00200096Memorial Sloan Kettering Cancer Center101
终止
不适用
Acupuncture for Chemo-Induced Peripheral Neuropathy in Multiple Myeloma PatientsChemotherapy-induced Peripheral NeuropathyNCT04770402Wake Forest University Health Sciences12
已完成
2 期
Acupressure for Post-Treatment Cancer FatigueFatigueNCT00959998University of Michigan43
终止
2 期
Acupuncture for the Treatment of Cancer Related FatigueFatigueNCT01572168Ann & Robert H Lurie Children's Hospital of Chicago7
已完成
不适用
Acupuncture for Chemical Therapy Induced Nausea and Vomiting: a Cross-over TrailChemotherapy-induced Nausea and VomitingNCT02127255Beijing University of Chinese Medicine39