The Relationship Between Intake of Macro and Micronutrients With Clinical Outcomes of Head and Neck Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Dr. Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Head and neck cancer adult patients who haven't undergone radiotherapy or chemotherapy, during radiotherapy, and after radiotherapy whose came to radiotherapy unit in Dr. Cipto Mangunkusumo Hospital, Jakarta during January 2021 to October 2021.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight	body weight in kilogram	after radiotherapy (1 day)
total lymphocyte count	TLC in 1000/mcL	before radiotherapy (1 day)
taste bud perception	Henkin test	before radiotherapy (1 day)
stomatitis	stomatitis grade using WHO criteria	during radiotherapy (1 day)
muscle mass	body composition analyzer, result in kg.	before radiotherapy (1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
protein intake	protein intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey	during the first meeting (1 day)
energy intake	energy intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey	during the first meeting (1 day)
BCAA intake	BCAA intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey	during the first meeting (1 day)
zinc intake	zinc intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey	during the first meeting (1 day)
hair zinc level	zinc level in hair	during the first meeting if the patients undergo radiotherapy (1 day)

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Yohannessa Wulandari, MD, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 20-08-0928

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No