Acupuncture for Mucositis Pain in Cancer Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Frequency of any adverse effects
研究概览
简要总结
This research is being done to see if acupuncture helps relieve mucositis pain in patients with leukemia who are undergoing chemotherapy. Many patients receiving chemotherapy develop mucositis (painful sores or blisters in the mouth or throat). Mucositis is not only a frequent complication in cancer care and extremely painful, but also increases the risks of infection and malnutrition and often leads to discontinuing or delaying the chemotherapy treatments.
详细描述
Acupuncture is one of the oldest, most commonly used medical procedures in the world. The practice originated in China more than 2,000 years ago, and is widely used by doctors in Korea, China, Japan, and other countries to ease pain or various symptoms. In the past two decades, acupuncture has grown in popularity in the United States, and by 2002, an estimated 8.2 million adults in the US report having used acupuncture.
The term acupuncture describes a family of procedures involving stimulation of anatomical points on the body by a variety of techniques. The acupuncture technique that has been most studied scientifically involves penetrating the skin with thin, solid, metallic needles that are manipulated by the hands or by electrical stimulation. Acupuncture needles are metallic, solid, and hair-thin. People experience acupuncture differently, but most feel no or minimal pain as the needles are inserted. Some people are energized by treatment, while others feel relaxed.
Acupuncture has been used to ease some cancer treatment-related side effects such as nausea and vomiting. In this study we will assess the potential usefulness of acupuncture to ease the pain associated with mucositis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with leukemia (such as acute myelogenous leukemia) and receiving chemotherapy for induction, consolidation or re-induction or high dose preparative regimen for bone marrow transplantation in the Johns Hopkins Oncology Inpatient Services
- •Participation in standard leukemia-treatment regimens
- •Expectation of survival of three weeks for completion of the study
排除标准
- •Acupuncture treatment within the previous 6 weeks
- •Unable to achieve platelet count of at least 10,000 with platelet support
- •Radiation therapy within one month of enrollment
- •Pregnant women
- •History of substance abuse, including alcohol and IV drug users
结局指标
主要结局
Frequency of any adverse effects
时间窗: 12 weeks
Bleeding, infection, bruising, etc
Compliance
时间窗: 12 weeks
Retention/ dropout rate
Sham credibility rate
时间窗: 12 weeks
次要结局
- Mucositis Grade(12 weeks)
- Pain levels(12 weeks)
- Total amount of conventional analgesics used and Total days on Analgesic(12 weeks)
