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临床试验/ACTRN12619000263190
ACTRN12619000263190终止未知

A randomised controlled trial comparing manual lymphatic drainage and compression in the management of head and neck lymphoedema following head and neck cancer treatment.

Princess Alexandra Hospital0 个研究点目标入组 5 人开始时间: 2019年2月20日最近更新:

试验速览

阶段
未知
状态
终止
入组人数
5

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

  • >18 years of age
  • A previous diagnosis of oral, nasopharyngeal, oropharyngeal, laryngeal, or hypopharyngeal cancer treated with chemoradiation, postoperative radiation or definitive radiation with curative intent
  • Life expectancy >12months
  • Able to provide informed written consent
  • MD Anderson Cancer Centre (MDACC) HNL rating >1 indicating soft visible oedema; no pitting, reversible

排除标准

  • Cancer recurrence
  • Previous radiotherapy and/or surgery to the neck, oral, pharyngeal, or laryngeal anatomic structures
  • Pharyngolaryngectomy or laryngectomy
  • Co-morbidity factors that may result in head and neck oedema and/or lymphoedema, or impact their swallowing and voice function; such as stroke, head and neck trauma, or neurological degenerative diseases.
  • Unable to attend follow up appointments at the study site
  • Facial hair precluding completion of external lymphoedema assessment
  • NIRFLI imaging only: Allergic to indocyanine green, sodium iodide or iodine, over-active thyroid, benign tumours of the thyroid, previous known side effects from indocyanine green injections, kidney failure.

研究者

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