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

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

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

Study Overview

• Status: Recruiting
• Conditions: Oral Nutritional Supplement
• Intervention / Treatment: Dietary supplement: immunonutrients oral nutritional supplements; Dietary supplement: standard oral nutritional supplements

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fuadiyah Nila, MPH; Phone Number: +6282226868412; Email: fuadiyah_nila.fk@ub.ac.id

Study Locations

• Indonesia
  • DI Yogyakarta
    • Yogyakarta, DI Yogyakarta, Indonesia, 55284
      • Recruiting
      • Dr. Sardjito General Hospital
      • Contact: Fuadiyah Nila; Phone Number: +6282226868412; Email: fuadiyahnila@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participant diagnosed with advanced stage head and neck cancer (stages 3 and 4) who received radiotherapy, both as concurrent and adjuvant or chemoradiotherapy
2. Participant aged 18-80 years
3. Participant can consume food, either through a nasogastric tube (NGT) or orally

Exclusion Criteria:

1. Participant has a milk or egg allergy
2. Participant with comorbid renal impairment and/or diabetes mellitus
3. Participant with poor nutritional status with BMI < 17.0 kg/m2

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immunonutrients ONS; the intervention group received ONS which contained immunonutrients (omega 3 and anthocyanin)	Dietary supplement: immunonutrients oral nutritional supplements; 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.
Active Comparator: standard ONS; the control group received standard ONS (isocaloric)	Dietary supplement: standard oral nutritional supplements; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Brawijaya
• Collaborators: Gadjah Mada University
• Investigators: Principal Investigator: Fuadiyah Nila, MPH, Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: radiotherapy; head and neck cancer; oral nutritional supplement; immunonutrient; purple sweet potato
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: UBrawijaya

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No