Clinical trial NCT03688646: Efficacy of ONS Supplementation in HNC Outpatient Under Treatment
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: National Cancer Institute, Malaysia
Sponsor class: OTHER_GOV
First posted: 2018-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: nutritional outcome (weight changes)
timeFrame: 7 weeks
measure: functional outcome
timeFrame: 7 weeks
measure: side effect outcome
timeFrame: 7 weeks
measure: nutritional outcome (body composition)
timeFrame: 7 weeks
measure: nutritional outcome (biochemical data - albumin and hemoglobin level)
timeFrame: 7 weeks
measure: nutritional outcome (body mass index)
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute (NCI)
name: Norshariza Jamhuri
role: PRINCIPAL_INVESTIGATOR
References: