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Efficacy of ONS Supplementation in HNC Outpatient Under Treatment

NCT03688646 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-09-28

No results posted yet for this study

Summary

A RCT study to compare the efficacy of ONS supplementation with standard dietary advice on nutritional outcome inHNC outpatients undergoing treatment in radiotherapy clinic. IThe study population are all adult HNC outpatients receiving radiotherapy with or without chemotherapy treatments at Radiotherapy Clinic,NCI. Selected patient will be randomized into Control Group and Intervention Group until each group have 20 subjects, where the total of sample will be 40 patients (in consideration of 50% dropouts) and data will be collected at baseline (prior to treatment), week 2, 4, and the final data will be at week 6 or final day of cancer treatment. Study objectives are to determine the efficacy of ONS supplementation in outpatient HNC undergoing treatment in Radiotherapy Clinic, NCI, to determine nutritional outcome (weight loss and BMI, body composition, dietary intake, albumin and hemoglobin level), functional outcome (handgrip strength) and side effect outcome (nutrition impact symptoms) in HNC outpatients given intensive nutrition intervention with outpatients given routine care. This study also want to find association of Intensive nutrition intervention versus routine care in nutrition outcome, functional and side effect outcome in both group. Subjects in intervention group will received standardize ONS supplementation every day during treatments once daily with frequent dietary advice accordingly to the patients condition while control group will received standard routine care which includes frequent dietary advice without supplementation of ONS. Study hypothesis is there is no significant difference in nutritional outcome, functional outcome and side effect outcome between HNC outpatients receiving INI when compared to HNC outpatient receiving routine care undergoing radiotherapy treatment. There is also no association between these two groups in nutritional outcome, functional outcome and side effect outcome.

Conditions

Interventions

DIETARY_SUPPLEMENT

Intensive Nutrition Intervention

Sponsors & Collaborators

  • National Cancer Institute, Malaysia

    lead OTHER_GOV

Principal Investigators

  • Norshariza Jamhuri · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03688646 on ClinicalTrials.gov