The Effect of Oral Nutrition Supplement Formulas (ONS) and Diet Counseling on Improvement of Nutritional Status, Knowledge, Attitudes, and Behavior of Cancer Patients

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ BMI/body mass index \<18.5 kg/m2 or

⁃ There is a \>10% weight loss in the last 3-6 months or

⁃ BMI \<20 kg/m2 or

⁃ 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.

Locations
Other Locations
Indonesia
Persahabatan General Hospital
RECRUITING
Jakarta
Contact Information
Primary
Sri AP Simanullang, B.Pharm
sri.simanullang@pharmametriclabs.com
+62 81255434018
Backup
Dedyanto H Saputra, MD
dedyanto.henky@kalbe.co.id
+62 81519102333
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2024-08-30
Participants
Target number of participants: 108
Treatments
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.
Sponsors
Leads: Kalbe International Pte. Ltd
Collaborators: Persahabatan Hospital

This content was sourced from clinicaltrials.gov