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

NCT05740878 | Unknown DMC

• 1 other identifier: UBrawijaya
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Nutritional Supplement

Keywords

oral nutritional supplement; immunonutrient; head and neck cancer; radiotherapy; purple sweet potato

Outcome Measures

Primary Outcomes (4)

• weight change

  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.

  immediately after the intervention

• Body mass index (BMI)

  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.

  immediately after the intervention

• mid-upper arm circumference (MUAC)

  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.

  immediately after the intervention

• handgrip strength

  a simple and reliable measurement of maximum voluntary muscle strength, that is measured with handgrip dynamometer in kilograms (kg) unit.

  immediately after the intervention

Study Arms (2)

immunonutrients ONS

EXPERIMENTAL

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

Dietary Supplement: immunonutrients oral nutritional supplements

standard ONS

ACTIVE COMPARATOR

the control group received standard ONS (isocaloric)

Dietary Supplement: standard oral nutritional supplements

Interventions

immunonutrients oral nutritional supplements DIETARY_SUPPLEMENT

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.

immunonutrients ONS

standard oral nutritional supplements DIETARY_SUPPLEMENT

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

standard ONS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Brawijaya: lead
• Gadjah Mada University: collaborator

Study Sites (1)

dr. Sardjito General Hospital

Yogyakarta, DI Yogyakarta, 55284, Indonesia

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Fuadiyah Nila, MPH

  Gadjah Mada University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuadiyah Nila, MPH

CONTACT

+6282226868412; fuadiyah_nila.fk@ub.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Brawijaya

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 23, 2023
• Study Start: March 15, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

ID (1)