Clinical trial NCT05740878: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Nutritional Supplement
Keywords: oral nutritional supplement
immunonutrient
head and neck cancer
radiotherapy
purple sweet potato
Lead sponsor: University of Brawijaya
Sponsor class: OTHER
Collaborators: name: Gadjah Mada University
First posted: 2023-02-23
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: weight change
timeFrame: immediately after the intervention
measure: Body mass index (BMI)
timeFrame: immediately after the intervention
measure: mid-upper arm circumference (MUAC)
timeFrame: immediately after the intervention
measure: handgrip strength
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: dr. Sardjito General Hospital
state: DI Yogyakarta
Study officials:
affiliation: Gadjah Mada University
name: Fuadiyah Nila, MPH
role: PRINCIPAL_INVESTIGATOR
References: