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临床试验/NCT03531190
NCT03531190已完成不适用

A Randomized Controlled Clinical Trial of Pre- and Postoperative Supplementation With Zinc, Vitamin C, Arginine and Multivitamin Mineral in Patients Treated for Head and Neck Cancer

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)

研究概览

简要总结

The purpose of the project is to investigate the effect of wound healing of a combined pre- and postoperative oral supplement, consisting of zinc, vitamin C, arginine and multivitamin, as a supplement for adequate nutrition in patients operated for head and neck cancer.

详细描述

The project will be conducted as an open, randomized intervention study, and includes patients with head and neck cancer that are planned for operation. 40 participants are allocated to the intervention or control group, respectively. For both groups, the experiment will last for five to six weeks, depending on when the trial participants are planned for surgery. The intervention group must take a dietary supplement and a protein drink for 35 days (7 days preoperatively and 28 days postoperatively), which is delivered 7 days preoperatively. The same applies to the control group that only receives protein drinks. The length of the intervention period is based on the design of previous studies. During the project, compliance will be evaluated by counting the amount of remaining dietary supplements and protein drinks that the participants return on a regular basis. The control group receives standard treatment as well as protein drinks. For all participants included in the experiment blood tests and an ultrasound scanning will be performed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Authorized/legal age (> 18 years)
  • Patients who understand written and oral Danish, and are able to give written consent
  • Patients diagnosed with head and neck cancer, which are set for surgery
  • Patients operated on the outside of the neck

排除标准

  • Patients who do not understand, speak or write Danish
  • Not Authorized/not legal age (<18 years)
  • Pregnant and breastfeeding women
  • Patients previously employed in the field of surgery within the last 5 years (prior years)

结局指标

主要结局

POSAS-scale (The Patient and Observer Scar Assessment Scale v2.0 / EN)

时间窗: 2 months

points on POSAS-questionaire (7-70)

次要结局

  • Ultrasound scanning(2 months)
  • Appearance of the scar (scale)(2 months)
  • Size of the scar (cm)(2 months)
  • Biochemical measurements (micromol/l) at start and finish(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jens Rikardt Andersen

Associate Professor

University of Copenhagen

研究点 (2)

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