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

University of Brawijaya

Status: Enrolling

Conditions: Oral Nutritional Supplement

Treatments: Dietary Supplement: immunonutrients oral nutritional supplements; Dietary Supplement: standard oral nutritional supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT05740878

UBrawijaya

Details and patient eligibility

About

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

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

immunonutrients ONS

Experimental group

Description:

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

Treatment:

Dietary Supplement: immunonutrients oral nutritional supplements

standard ONS

Active Comparator group

Description:

the control group received standard ONS (isocaloric)

Treatment:

Dietary Supplement: standard oral nutritional supplements