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临床试验/NCT05226065
NCT05226065已完成不适用

The Relationship Between Intake of Macro and Micronutrients With Clinical Outcomes of Head and Neck Cancer Patients at the Radiotherapy Unit of Dr. Cipto Mangunkusumo Hospital

Indonesia University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2021年1月1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
112
试验地点
1
主要终点
total lymphocyte count

研究概览

简要总结

Cancer is a disease caused by uncontrolled cells growth, and its incidence is increasing worldwide. One of the most common cancer is head and neck cancer (HNC), which has low survival rate. Malnutrition occurrence in HNC lower immune system and as result, decreased survival rate was found. Risk factors including tumor histopathology, nutritional status, immune system, and environment have various effects on life expectancy.

Head and neck cancer treatments such as radiotherapy, chemotherapy, and surgery are not without complications. Xerostomia, stomatitis, anorexia, nausea and vomiting, dysgeusia, ageusia, also pain are commonly found during the HNC treatment procedure, and takes part in further undernutrition findings in HNC patients.

Adequate nutrition management has favorable impact in managing HNC patients' malnutrition related problems. Not only energy intake, but also macronutrients and micronutrients intake have been proved be beneficial in the outcomes of HNC patients. Branched-chain amino acids (BCAA) and zinc are namely two nutrients that have been hypothesized to be beneficent. Branched-chain amino acids are found to increase muscle mass, amino acid pools, and immune system, which resulted in preventing malnutrition and cachexia, also increasing total lymphocyte count in cancer patients. Zinc plays role in immune system, antioxidant process, and taste bud functions. Zinc supplementation is correlated to give a better outcome in taste perception and stomatitis in HNC patients who undergo radiotherapy.

This study aims to finds the correlation between BCAA intake with muscle mass and lymphocyte count in HNC patients who haven't undergone chemoradiotherapy, zinc correlation with gustatory in HNC patients who haven't undergone chemoradiotherapy, zinc correlation with stomatitis in HNC patients who is having radiotherapy treatment, and energy and protein intake with body weight in HNC patients after underwent radiotherapy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • head and neck cancer patients who haven't undergone radiotherapy or chemotherapy, during radiotherapy, and after radiotherapy

排除标准

  • have contraindications for body composition measuring
  • are immunodeficient or have autoimmune disease
  • during immunosuppressant drugs treatment

结局指标

主要结局

total lymphocyte count

时间窗: before radiotherapy (1 day)

TLC in 1000/mcL

taste bud perception

时间窗: before radiotherapy (1 day)

Henkin test

body weight

时间窗: after radiotherapy (1 day)

body weight in kilogram

stomatitis

时间窗: during radiotherapy (1 day)

stomatitis grade using WHO criteria

muscle mass

时间窗: before radiotherapy (1 day)

body composition analyzer, result in kg.

次要结局

  • protein intake(during the first meeting (1 day))
  • energy intake(during the first meeting (1 day))
  • BCAA intake(during the first meeting (1 day))
  • hair zinc level(during the first meeting if the patients undergo radiotherapy (1 day))
  • zinc intake(during the first meeting (1 day))

研究者

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

dr. Yohannessa Wulandari, M.Gizi, Sp GK

Principal Investigator

Indonesia University

研究点 (1)

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