Efficacy of ONS Supplementation in HNC Outpatient Under Treatment

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03688646
• Other study ID #: NMRR-15-2171-28670
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016

Study information

• Verified date: September 2018
• Source: National Cancer Institute, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Dietary Supplement:
• Intensive Nutrition Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Malaysia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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