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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05226065
Other study ID # 20-08-0928
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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