Clinical Trial Finder

Inclusion Criteria:

• - Histologically confirmed lung and ob-gyn cancer patients (who have not undergone therapy or are currently undergoing therapy) - Aged greater than or equal to 18 years.

• - Patients with a performance status score of 0 - 2.

• - Have inadequate food intake >5 days or: 1.

BMI/body mass index <18.5 kg/m2 or. 2. There is a >10% weight loss in the last 3-6 months or. 3. BMI <20 kg/m2 or. 4. There is >5% weight loss in the last 3-6 months with.

• - Intervention group subjects are willing to take ONS orally for 8 weeks.

• - Intervention group subjects, if they have taken other brands of ONS, are willing to stop taking ONS 2 weeks prior to the study.

Exclusion Criteria:

• - Pregnant and breastfeeding, except for female subjects with one of the following criteria: 1.

Have a history of hysterectomy (surgical removal of the uterus) and/or bilateral oophorectomy (surgical removal of the ovaries). 2. Medically confirmed ovarian failure (decreased ovarian function) 3. Achieved post menopausal status, defined as: cessation of regular menstruation for at least 12 consecutive months in the absence of pathological or physiological causes. - Renal insufficiency (eGFR ( Estimated Glomerular Filtration Rate ) <15 mL/min/1.73 m2 or significant increase in urea/creatinine or having to be on a low protein diet) - Liver insufficiency (SGOT (Serum Glutamic Oxaloacetic Transaminase) /SGPT (Serum Glutamic Pyruvic Transaminase) values ≥3 times the normal limit)

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), quality of life, 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.

Arms

Experimental: ONS (oral nutrition supplement) group

ONS will be consumed 3 times a day, for 8 weeks. Per serving/sachet ONS (±81g) contains 350 kcal of energy, 9 g of fat, 20 g of protein, 48 g of carbohydrates, 400 mg of DHA (Docosahexaenoic acid), 300 mg of EPA (Eicosapentaenoic Acid) 0.92 g of Omega-3, 1 g of L-Valine, 2.1 g of L-. Isoleucine 1.1 g, L-Leucine 2.1 g, Sodium 75 mg, 12 vitamins and 9 minerals. Consumed as a morning snack (between breakfast and lunch); afternoon snack (between lunch and dinner) and evening snack (before bedtime). Subject will also received dietary counseling for 8 weeks

No Intervention: Control group

only received dietary counseling for 8 weeks without ONS supplementation.

Interventions

Dietary Supplement: - NUTRICAN

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.