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临床试验/ACTRN12615001152516
ACTRN12615001152516招募中未知

Feasibility study: Targeting post cancer fatigue among women and men with breast cancer using acupuncture compared with treatment as usual

Western Sydney University0 个研究点目标入组 20 人开始时间: 2015年10月29日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1) diagnosis of stage I, II, or III BC, who have completed breast surgery, adjuvant or neo-adjuvant chemotherapy and/or adjuvant radiotherapy between one month to 2 years prior to enrolment and who have not developed recurrent disease in the intervening period between diagnosis and study recruitment.
  • 2) Taking adjuvant endocrine therapy and trastuzumab (Herceptin) are eligible
  • 3) Ongoing cancer related fatigue, defined as a score of 4 or more on the fatigue sub scale of the Somatic and Psychological Health Report (SPHERE) questionnaire
  • 4) Normal coagulation coagulation studies: PT, APTT, INR at baseline or within the previous 1 month.
  • 5) Adequate haematological parameters at baseline or within the previous 1 month: Hb greater than 100, ANC greater than 1.0, Platelet count greater than 150.

排除标准

  • 1) Co-morbid medical conditions expected to cause ongoing fatigue, (e.g.co-morbidity significant anaemia (defined as Hb less than 100) or thyroid disease) as assessed by the investigator.
  • 2) Current use of acupuncture.
  • 3) Needle phobia.
  • 4) Concurrent treatment with medication interfering with blood clotting or bleeding time, including heparin and fractionated heparin, vitamin K antagonists, direct thrombin inhibiitors, factor Xa inhibitors, and antiplatelet agents.
  • 5) Life expectancy less than six months.
  • 6) Plan for major surgery during the time of the study e.g. breast reconstruction or re-excision.
  • 7) History of other malignany within 5 years of recruitment, other than CIN of cervix or non-melanomatous skin cancers.

研究者

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