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

NCT05226065 | Completed DMC

• 1 other identifier: 20-08-0928
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• protein intake

  during the first meeting (1 day)

• energy intake

  during the first meeting (1 day)

• BCAA intake

  during the first meeting (1 day)

• zinc intake

  during the first meeting (1 day)

• hair zinc level

  during the first meeting if the patients undergo radiotherapy (1 day)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (1)

• Kristian YY, Cahyanur R, Wulandari Y, Sinaga W, Lukito W, Prasetyawaty F, Lestari W. Correlation between branched-chain amino acids intake and total lymphocyte count in head and neck cancer patients: a cross-sectional study. BMC Nutr. 2023 Jul 14;9(1):86. doi: 10.1186/s40795-023-00746-5.

  PMID: 37452428 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Yohannessa Wulandari, MD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 7, 2022
• Study Start: January 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

ID (1)