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Administration of ONS Based on Purple Sweet Potato in Head and Neck Cancer Patients With Radiotherapy
Study Purpose
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 responseRecruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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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/m2Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
Arms
Experimental: immunonutrients ONS
the intervention group received ONS which contained immunonutrients (omega 3 and anthocyanin)
Active Comparator: standard ONS
the control group received standard ONS (isocaloric)
Interventions
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.
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
Contact a Trial Team
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International Sites
Status
Recruiting
Address
dr. Sardjito General Hospital
Yogyakarta, DI Yogyakarta, 55284
Site Contact
Fuadiyah Nila
[email protected]
+6282226868412
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