Effect of NUTRICAN to Improve Nutritional Status in Cancer Patients

November 7, 2023 updated by: Kalbe International Pte. Ltd

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

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Recruiting
        • Persahabatan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
No Intervention: Control group
only received dietary counseling for 8 weeks without ONS supplementation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition consumption knowledge score
Time Frame: 8 weeks

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);
8 weeks
Nutrition consumption attitude score
Time Frame: 8 weeks

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)
8 weeks
Nutrition consumption behaviour score
Time Frame: 8 weeks

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).
8 weeks
Nutritional status by body weight
Time Frame: 8 weeks
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.
8 weeks
Nutritional status by body mass index
Time Frame: 8 weeks

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)
8 weeks
Nutritional status by haemoglobin
Time Frame: 8 weeks
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.
8 weeks
Nutritional status by albumin
Time Frame: 8 weeks
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calorie intake
Time Frame: 8 weeks
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.
8 weeks
Protein intake
Time Frame: 8 weeks
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
8 weeks
Quality of life with QLC-30 score
Time Frame: 8 weeks

The change in quality of life between ONS group vs control group; assessed by QLC-C30 (Quality of Life Questionnaire Core-30) score after 8 weeks of intervention. QLC-C30 is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.

Interpretation of QLC-C30 score: a.Good ≥1000 b.Moderate = 500-1000 c.Poor ≤500
8 weeks
Inflammatory status by CRP
Time Frame: 8 weeks
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.
8 weeks
Inflammatory status by IL-1
Time Frame: 8 weeks
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.
8 weeks
Inflammatory status by IL-6
Time Frame: 8 weeks
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.
8 weeks
Inflammatory status by TNF-α
Time Frame: 8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kalbe International Pte. Ltd

Collaborators

Persahabatan Hospital

Investigators

  • Principal Investigator: Elisna Syahruddin, Phd.MD, Persahabatan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

November 1, 2023

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

November 7, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Constatine Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

Starting December 2023

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal. For more information or to submit a request, please contact: dedyanto.henky@kalbe.co.id

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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