Clinical trial NCT06128694: Effect of NUTRICAN to Improve Nutritional Status in Cancer Patients
Official title: The Effect of Oral Nutrition Supplement Formulas (ONS) and Diet Counseling on Improvement of Nutritional Status, Knowledge, Attitudes, and Behavior of Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Malnutrition; Protein
Cancer, Lung
Cancer Cervix
Keywords: malnutrition
oral nutrition supplement
cancer
Nutrican
Lead sponsor: Kalbe International Pte. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Persahabatan Hospital
First posted: 2023-11-13
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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?

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), 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Nutrition consumption knowledge score
timeFrame: 8 weeks
measure: Nutrition consumption attitude score
timeFrame: 8 weeks
measure: Nutrition consumption behaviour score
timeFrame: 8 weeks
measure: Nutritional status by body weight
timeFrame: 8 weeks
measure: Nutritional status by body mass index
timeFrame: 8 weeks
measure: Nutritional status by haemoglobin
timeFrame: 8 weeks
measure: Nutritional status by albumin
timeFrame: 8 weeks
Secondary outcomes:
measure: Calorie intake
timeFrame: 8 weeks
measure: Protein intake
timeFrame: 8 weeks
measure: Inflammatory status by CRP
timeFrame: 8 weeks
measure: Inflammatory status by IL-1
timeFrame: 8 weeks
measure: Inflammatory status by IL-6
timeFrame: 8 weeks
measure: Inflammatory status by TNF-α
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Persahabatan General Hospital
Study officials:
affiliation: Persahabatan Hospital
name: Elisna Syahruddin, Phd.MD
role: PRINCIPAL_INVESTIGATOR
References: