Effect of NUTRICAN to Improve Nutritional Status in Cancer Patients

Last updated: July 28, 2024
Sponsor: Kalbe International Pte. Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Diet And Nutrition

Weight Loss

Treatment

NUTRICAN

Clinical Study ID

NCT06128694
Constatine Study
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed lung and ob-gyn cancer patients (who have not undergonetherapy 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 tostop taking ONS 2 weeks prior to the study.

Exclusion

Exclusion Criteria:

  • Pregnant and breastfeeding, except for female subjects with one of the followingcriteria:
  1. Have a history of hysterectomy (surgical removal of the uterus) and/orbilateral oophorectomy (surgical removal of the ovaries).

  2. Medically confirmed ovarian failure (decreased ovarian function)

  3. Achieved post menopausal status, defined as: cessation of regular menstruationfor at least 12 consecutive months in the absence of pathological orphysiological causes.

  • Renal insufficiency (eGFR ( Estimated Glomerular Filtration Rate ) <15 mL/min/1.73m2 or significant increase in urea/creatinine or having to be on a low protein diet)

  • Liver insufficiency (SGOT (Serum Glutamic Oxaloacetic Transaminase) /SGPT (SerumGlutamic Pyruvic Transaminase) values ≥3 times the normal limit)

Study Design

Total Participants: 108
Treatment Group(s): 1
Primary Treatment: NUTRICAN
Phase: 3
Study Start date:
August 01, 2023
Estimated Completion Date:
August 30, 2024

Study 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), 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.

Connect with a study center

  • Persahabatan General Hospital

    Jakarta, 13230
    Indonesia

    Active - Recruiting

  • Persahabatan Hospital

    Jakarta,
    Indonesia

    Active - Recruiting

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