Administration of ONS Based on Purple Sweet Potato in Head and Neck Cancer Patients With Radiotherapy
- Conditions
- Oral Nutritional Supplement
- Interventions
- Dietary Supplement: immunonutrients oral nutritional supplementsDietary Supplement: standard oral nutritional supplements
- Registration Number
- NCT05740878
- Lead Sponsor
- University of Brawijaya
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 58
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description immunonutrients ONS immunonutrients oral nutritional supplements the intervention group received ONS which contained immunonutrients (omega 3 and anthocyanin) standard ONS standard oral nutritional supplements the control group received standard ONS (isocaloric)
- Primary Outcome Measures
Name Time Method Body mass index (BMI) immediately after the intervention 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.
weight change immediately after the intervention 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.
handgrip strength immediately after the intervention a simple and reliable measurement of maximum voluntary muscle strength, that is measured with handgrip dynamometer in kilograms (kg) unit.
mid-upper arm circumference (MUAC) immediately after the intervention 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
dr. Sardjito General Hospital
🇮🇩Yogyakarta, DI Yogyakarta, Indonesia