Administration of ONS Based on Purple Sweet Potato in Head and Neck Cancer Patients With Radiotherapy

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on nutritional status and inflammatory response in head and neck cancer patients receiving radiotherapy. The main questions it aims to answer are: Is there any effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on the nutritional status? Is there any effect of local food-based oral nutritional supplements (ONS) containing immunonutrients (omega-3 and anthocyanins) on inflammatory response? Participants will participants will receive ONS in powder form ready to brew as much as 2 servings per day for 3 weeks. Researchers will compare the effect of giving ONS containing immunonutrients compared to standard ONS to see the effect on nutritional status and inflammatory response

Detailed Description
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The intervention group received ONS which contained immunonutrients with a composition consisting of purple sweet potato flour, egg white flour, whey protein, olive oil, omega 3 powder, sugar, and creamer. While the control group received a placebo in the form of standard ONS (isocaloric) with a composition of powdered skim milk, coconut oil, sugar, maltodextrin, and creamer.

Official Title
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Effect of Local Food-Based Oral Nutritional Supplements (ONS) Containing Immunonutrients in the Form of Anthocyanin and Omega-3 on Nutritional Status and Inflammatory Response in Head and Neck Cancer Patients Receiving Radiotherapy

Conditions
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Oral Nutritional Supplement

Intervention / Treatment
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* Dietary Supplement: immunonutrients oral nutritional supplements
* Dietary Supplement: standard oral nutritional supplements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant diagnosed with advanced stage head and neck cancer (stages 3 and 4) who received radiotherapy, both as concurrent and adjuvant or chemoradiotherapy Participant aged 18-80 years Participant can consume food, either through a nasogastric tube (NGT) or orally Exclusion Criteria: Participant has a milk or egg allergy Participant with comorbid renal impairment and/or diabetes mellitus Participant with poor nutritional status with BMI < 17.0 kg/m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immunonutrients ONS<br>the intervention group received ONS which contained immunonutrients (omega 3 and anthocyanin) | Dietary Supplement: immunonutrients oral nutritional supplements<br>* 1 serving of ONS immunonutrients which is 57 grams of ready-to-brew powder yields 200 ml of a liquid formula containing 251 kcal energy (1.26 kcal/ml), 9 grams protein (14%), 94 mg omega-3, and 20 mg anthocyanins.<br>|
| Active Comparator: standard ONS<br>the control group received standard ONS (isocaloric) | Dietary Supplement: standard oral nutritional supplements<br>* 1 serving of standard ONS which is 57 grams of ready-to-brew powder yields 200 ml of liquid formula containing 258 kcal energy (1.26 kcal/ml), 5 g (7.5%) protein , 7 g (24%) fat, 43 g (68%) carbohydrate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight change | The differences in body weight after and before the intervention was given. Weight in kilograms will be measured with digital scales Omron Type HBF 378. | immediately after the intervention | 
| Body mass index (BMI) | Calculation of nutritional status using the ratio of body weight (kg) to height squared (m2), where body weight is measured using an digital scales Omron Type HBF 378 and height is measured with a stadiometer. | immediately after the intervention | 
| mid-upper arm circumference (MUAC) | the circumference of the left upper arm, measured at the mid-point between the tip of the shoulder and the tip of the elbow (olecranon process and the acromion). MUAC is measured using a metline in centimeters. | immediately after the intervention | 
| handgrip strength | a simple and reliable measurement of maximum voluntary muscle strength, that is measured with handgrip dynamometer in kilograms (kg) unit. | immediately after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral nutritional supplement, immunonutrient, head and neck cancer, radiotherapy, purple sweet potato