The goal of this clinical trial is to evaluate the efficacy oral nutrition supplement (ONS) in malnutrition/high risk malnutrition cancer patients. The main questions it aims to answer: 1. Are there differences in knowledge, attitude and behaviour scores in cancer patients who receive cancer-specific ONS compared to those who do not receive cancer-specific ONS? 2. Is there a difference in nutritional status as assessed by average body weight, body mass index (BMI), haemoglobin (Hb), and albumin levels in cancer patients who receive cancer-specific ONS compared to those who do not receive cancer-specific ONS?
This study uses an open label randomized clinical trial (RCT) design, double arm which allows subjects and researchers to know the interventions received by subjects conducted on cancer patient subjects. The study aims to compare knowledge, attitudes, and actions related to nutrition consumption through questionnaires, nutritional status assessed from anthropometry (BW and BMI), nutrient intake, as well as laboratory results (Hb, serum albumin), and inflammatory markers (CRP, TNF-α, IL(interleukin)-1, IL-6) between the group of subjects who were given dietary counseling and ONS/oral nutrition supplement (intervention group) for 8 weeks compared to the group of subjects who only received dietary counseling and did not receive ONS (control group). Subjects who meet the inclusion criteria will be randomized into 2 groups using the stratified block randomization method stratified by age, and cancer type. Randomization will be carried out using a system in the application by stratifying the age of the subject based on the categorical age which has been categorized into 18-45 years and \>45 years. For the type of cancer stratified into two, namely lung cancer and gynecology cancer according to the inclusion criteria. Both stratified will be randomized using excel application that will randomize 80 subjects at the beginning of the research study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
108
Per serving/sachet NUTRICAN (±81g) contains 350 kcal energy, 9 g fat, 20 g protein, 48 g carbohydrate, 400 mg DHA, 300 mg EPA, 0.92 g Omega-3, 1 g L-Valine, 1.1 g L-Isoleucine, 2.1 g L-Leucine, 75 mg sodium, 12 vitamins and 9 minerals.
Persahabatan General Hospital
Jakarta, Indonesia
RECRUITINGNutrition consumption knowledge score
To determine changes in nutrition consumption knowledge scores in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after 8 weeks of intervention using questioner . Interpretation Knowledge score (5 questions): good (score\>=8 ) moderate (score 5-8) poor (score 0-4);
Time frame: 8 weeks
Nutrition consumption attitude score
To determine changes in nutrition consumption attitudes score in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after 8 weeks of intervention using questioner . Interpretation Attitude score (10 questions): good (score\>=30 ) moderate (score 21-30) poor (score 0-20)
Time frame: 8 weeks
Nutrition consumption behaviour score
To determine changes in nutrition consumption behavior in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after 8 weeks of intervention using questioner . Interpretation Behaviour score(10 questions): good (score\>=30 ) moderate (score 21-30) poor (score 0-20).
Time frame: 8 weeks
Nutritional status by body weight
To determine changes in BW (body weight in kg) in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after the 8-week intervention. The higher the increase in BW, the better.
Time frame: 8 weeks
Nutritional status by body mass index
To determine changes in BMI (body mass index in kg/m2) in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after the 8-week intervention. The higher the increase in BMI, the better. BMI is calculated as weight in kilograms divided by the square of the height in meters (kg/m2) and is categorized into four groups according to the cutoff points: underweight (\<18.5 kg/m2), normal weight (18.5-22.9 kg/m2), overweight (23-24.9 kg/m2), obese grade 1 (≥25-29 kg/m2) and obese grade 2 (\>29 kg/m2)
Time frame: 8 weeks
Nutritional status by haemoglobin
To determine changes in Hb (haemoglobin in mg/dL) level in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after the 8-week intervention. The higher the increase in haemoglobin level, the better.
Time frame: 8 weeks
Nutritional status by albumin
To determine changes in Albumin level (g/dL) in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after the 8-week intervention. The higher the increase in albumin level, the better
Time frame: 8 weeks
Calorie intake
Changes in calorie intake between ONS group vs control group after an 8-week intervention. Assessment of calorie intake using NutriSurvey 2007, Food Recall 2x24h \& Food Record 3x24h. The higher subject's calorie (kcal) intake ,the better.
Time frame: 8 weeks
Protein intake
Changes in protein intake between ONS group vs control group after an 8-week intervention. Assessment of protein intake using NutriSurvey 2007, Food Recall 2x24h \& Food Record 3x24h. The higher subject's protein (gram) intake ,the better
Time frame: 8 weeks
Inflammatory status by CRP
The change in inflammatory status between ONS group vs control group assessed by CRP(C-reactive protein in mg/L) level (using CRP Latex Kit) after the 8-week intervention. The lower the value of CRP, the better.
Time frame: 8 weeks
Inflammatory status by IL-1
The change in inflammatory status between ONS group vs control group assessed by IL-1 (interleukin-1 in pg/ml) level (using IL-1 ELISA kit) after the 8-week intervention The lower the value of IL-1, the better.
Time frame: 8 weeks
Inflammatory status by IL-6
The change in inflammatory status between ONS group vs control group assessed by IL-6 (interleukin-6 in pg/ml) level (using IL-6 ELISA kit) after the 8-week intervention. The lower the value of IL-6, the better.
Time frame: 8 weeks
Inflammatory status by TNF-α
The change in inflammatory status between ONS group vs control group assessed by TNF-α (Tumor necrosis factor alpha in pg/ml) level (using Kit Quantikine ELISA Human TNF- α) after the 8-week intervention. The lower the value of TNF-α, the better.
Time frame: 8 weeks
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