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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05226065
• Other study ID #: 20-08-0928
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Locations

Country	Name	City	State
Indonesia	Dr. Cipto Mangunkusumo Hospital	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	body weight in kilogram	after radiotherapy (1 day)
Primary	total lymphocyte count	TLC in 1000/mcL	before radiotherapy (1 day)
Primary	taste bud perception	Henkin test	before radiotherapy (1 day)
Primary	stomatitis	stomatitis grade using WHO criteria	during radiotherapy (1 day)
Primary	muscle mass	body composition analyzer, result in kg.	before radiotherapy (1 day)
Secondary	protein intake	protein intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey	during the first meeting (1 day)
Secondary	energy intake	energy intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey	during the first meeting (1 day)
Secondary	BCAA intake	BCAA intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey	during the first meeting (1 day)
Secondary	zinc intake	zinc intake using food frequency questionnaire and 24-hrs food recall, data calculated using nutrisurvey	during the first meeting (1 day)
Secondary	hair zinc level	zinc level in hair	during the first meeting if the patients undergo radiotherapy (1 day)