Efficacy of ONS Supplementation in HNC Outpatient Under Treatment

National Cancer Institute, Malaysia

Status: Unknown

Conditions: Head and Neck Cancer

Treatments: Dietary Supplement: Intensive Nutrition Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03688646

NMRR-15-2171-28670

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Intensive Nutrition Intervention

Control group

No Intervention group

Description:

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