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

Primary Purpose

Oral Nutritional Supplement

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
immunonutrients oral nutritional supplements
standard oral nutritional supplements
Sponsored by
University of Brawijaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Nutritional Supplement focused on measuring oral nutritional supplement, immunonutrient, head and neck cancer, radiotherapy, purple sweet potato

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • dr. Sardjito General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

immunonutrients ONS

standard ONS

Arm Description

the intervention group received ONS which contained immunonutrients (omega 3 and anthocyanin)

the control group received standard ONS (isocaloric)

Outcomes

Primary Outcome Measures

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.
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.
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.
handgrip strength
a simple and reliable measurement of maximum voluntary muscle strength, that is measured with handgrip dynamometer in kilograms (kg) unit.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2023
Last Updated
February 22, 2023
Sponsor
University of Brawijaya
Collaborators
Gadjah Mada University
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1. Study Identification

Unique Protocol Identification Number
NCT05740878
Brief Title
Administration of ONS Based on Purple Sweet Potato in Head and Neck Cancer Patients With Radiotherapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brawijaya
Collaborators
Gadjah Mada University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Nutritional Supplement
Keywords
oral nutritional supplement, immunonutrient, head and neck cancer, radiotherapy, purple sweet potato

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
immunonutrients ONS
Arm Type
Experimental
Arm Description
the intervention group received ONS which contained immunonutrients (omega 3 and anthocyanin)
Arm Title
standard ONS
Arm Type
Active Comparator
Arm Description
the control group received standard ONS (isocaloric)
Intervention Type
Dietary Supplement
Intervention Name(s)
immunonutrients oral nutritional supplements
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
standard oral nutritional supplements
Intervention Description
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
Primary Outcome Measure Information:
Title
weight change
Description
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.
Time Frame
immediately after the intervention
Title
Body mass index (BMI)
Description
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.
Time Frame
immediately after the intervention
Title
mid-upper arm circumference (MUAC)
Description
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.
Time Frame
immediately after the intervention
Title
handgrip strength
Description
a simple and reliable measurement of maximum voluntary muscle strength, that is measured with handgrip dynamometer in kilograms (kg) unit.
Time Frame
immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuadiyah Nila, MPH
Phone
+6282226868412
Email
fuadiyah_nila.fk@ub.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuadiyah Nila, MPH
Organizational Affiliation
Gadjah Mada University
Official's Role
Principal Investigator
Facility Information:
Facility Name
dr. Sardjito General Hospital
City
Yogyakarta
State/Province
DI Yogyakarta
ZIP/Postal Code
55284
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuadiyah Nila
Phone
+6282226868412
Email
fuadiyahnila@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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