Clinical trial NCT05226065: The Relationship Between Intake of Macro and Micronutrients With Clinical Outcomes of Head and Neck Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: body weight
timeFrame: after radiotherapy (1 day)
measure: total lymphocyte count
timeFrame: before radiotherapy (1 day)
measure: taste bud perception
timeFrame: before radiotherapy (1 day)
measure: stomatitis
timeFrame: during radiotherapy (1 day)
measure: muscle mass
timeFrame: before radiotherapy (1 day)
Secondary outcomes:
measure: protein intake
timeFrame: during the first meeting (1 day)
measure: energy intake
timeFrame: during the first meeting (1 day)
measure: BCAA intake
timeFrame: during the first meeting (1 day)
measure: zinc intake
timeFrame: during the first meeting (1 day)
measure: hair zinc level
timeFrame: during the first meeting if the patients undergo radiotherapy (1 day)
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo Hospital
state: Jakarta
Study officials:
affiliation: Indonesia University
name: Yohannessa Wulandari, MD
role: PRINCIPAL_INVESTIGATOR
References: