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Trial Title:
Administration of ONS Based on Purple Sweet Potato in Head and Neck Cancer Patients With Radiotherapy
NCT ID:
NCT05740878
Condition:
Oral Nutritional Supplement
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
oral nutritional supplement
immunonutrient
head and neck cancer
radiotherapy
purple sweet potato
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
immunonutrients oral nutritional supplements
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.
Arm group label:
immunonutrients ONS
Intervention type:
Dietary Supplement
Intervention name:
standard oral nutritional supplements
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
Arm group label:
standard ONS
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
dr. Sardjito General Hospital
Address:
City:
Yogyakarta
Zip:
55284
Country:
Indonesia
Status:
Recruiting
Contact:
Last name:
Fuadiyah Nila
Phone:
+6282226868412
Email:
fuadiyahnila@gmail.com
Start date:
March 15, 2022
Completion date:
May 30, 2023
Lead sponsor:
Agency:
University of Brawijaya
Agency class:
Other
Collaborator:
Agency:
Gadjah Mada University
Agency class:
Other
Source:
University of Brawijaya
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740878
