Efficacy of ONS Supplementation in HNC Outpatient Under Treatment

Randomised Control Trial Study To Compare The Efficacy of ONS Supplementation With Standard Dietary Advice On Nutritional Outcome in HNC Outpatients Undergoing Treatment in Radiotherapy Clinic

A RCT study to compare the efficacy of ONS supplementation with standard dietary advice on nutritional outcome inHNC outpatients undergoing treatment in radiotherapy clinic. IThe study population are all adult HNC outpatients receiving radiotherapy with or without chemotherapy treatments at Radiotherapy Clinic,NCI. Selected patient will be randomized into Control Group and Intervention Group until each group have 20 subjects, where the total of sample will be 40 patients (in consideration of 50% dropouts) and data will be collected at baseline (prior to treatment), week 2, 4, and the final data will be at week 6 or final day of cancer treatment. Study objectives are to determine the efficacy of ONS supplementation in outpatient HNC undergoing treatment in Radiotherapy Clinic, NCI, to determine nutritional outcome (weight loss and BMI, body composition, dietary intake, albumin and hemoglobin level), functional outcome (handgrip strength) and side effect outcome (nutrition impact symptoms) in HNC outpatients given intensive nutrition intervention with outpatients given routine care. This study also want to find association of Intensive nutrition intervention versus routine care in nutrition outcome, functional and side effect outcome in both group. Subjects in intervention group will received standardize ONS supplementation every day during treatments once daily with frequent dietary advice accordingly to the patients condition while control group will received standard routine care which includes frequent dietary advice without supplementation of ONS. Study hypothesis is there is no significant difference in nutritional outcome, functional outcome and side effect outcome between HNC outpatients receiving INI when compared to HNC outpatient receiving routine care undergoing radiotherapy treatment. There is also no association between these two groups in nutritional outcome, functional outcome and side effect outcome.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Dietary supplement: Intensive Nutrition Intervention

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Those who diagnosed with Head and Neck Cancer (HNC) and receiving radiotherapy with or without chemotherapy treatments.
2. Able to communicate.
3. Patient admitted to ward less than 5 days.

Exclusion Criteria:

1. Patient on tube feeding.
2. Patient was already on ONS before study period.
3. Patient already started treatments (referring to chemotherapy, radiotherapy and CCRT) before study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intensive nutrition intervention group receiving standardised oral nutrition supplement provided once daily throughout cancer treatment with 4 session of dietary consultation by designated dietitian for monitoring of diet intake and diet modification to meet patient's requirement	Dietary supplement: Intensive Nutrition Intervention
No Intervention: Control group; Routine care were given to this group inclusive of 4 session of dietary consultation by designated dietitian for monitoring of diet intake and diet modification to meet patient's requirement and also prescription of oral nutrition supplement where needed. Oral nutrition supplement was not provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nutritional outcome (weight changes)	changes of outcome within and between group weight in kilogram measurement are taken during baseline, 2nd weeks, 4th weeks and 6th weeks of treatment	7 weeks
functional outcome	preliminary handgrip strength and changes handgrip strength in kilogram force instrument: handgrip dynamometer measurement taken during baseline, 2nd week, 4th weeks and 6th weeks of treatment instrument: body composition analyzer changes of outcome within and between group	7 weeks
side effect outcome	changes of nutrition impact symptoms experienced by patients within and between group instrument: validated HSNC© checklist measured during baseline, 2nd weeks, 4th weeks, and 6th weeks of treatment	7 weeks
nutritional outcome (body composition)	muscle mass in kilogram body fat mass in kilogram measurement taken during baseline, 2nd week, 4th weeks and 6th weeks of treatment instrument: body composition analyzer changes of outcome within and between group	7 weeks
nutritional outcome (biochemical data - albumin and hemoglobin level)	albumin in g/L hemoglobin in g/dL measurement taken during baseline, 2nd week, 4th weeks and 6th weeks of treatment instrument: body composition analyzer changes of outcome within and between group	7 weeks
nutritional outcome (body mass index)	body mass in kilogram/meter2 measurement taken during baseline, 2nd week, 4th weeks and 6th weeks of treatment instrument: body composition analyzer changes of outcome within and between group	7 weeks

Collaborators and Investigators

• Sponsor: National Cancer Institute, Malaysia
• Investigators: Principal Investigator: Norshariza Jamhuri, National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: NMRR-15-2171-28670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO