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临床试验/NCT00549835
NCT00549835撤回不适用

Acupuncture for Mucositis Pain in Cancer Care

Johns Hopkins University1 个研究点 分布在 1 个国家开始时间: 2007年8月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (1)

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