Effect of NUTRICAN to Improve Nutritional Status in Cancer Patients

Status Recruiting

Clinical Trial 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?

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06128694
Study type	Interventional
Source	Kalbe International Pte. Ltd
Contact	Sri AP Simanullang, B.Pharm
Phone	+62 81255434018
Email	sri.simanullang@pharmametriclabs.com
Status	Recruiting
Phase	Phase 3
Start date	August 1, 2023
Completion date	February 28, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06152419` - Patient Education Videos to Improve Patients' Experience During Radiotherapy Treatment: a National Project	N/A
Recruiting	`NCT04105647` - Lifestyle Modification Program for Lung Cancer Patients - A Pilot Study	N/A
Completed	`NCT05732350` - Exploratory Drug Interaction Study Between SMIs and DOACs
Active, not recruiting	`NCT04300244` - Nivolumab and Ipilimumab +/- UV1 Vaccination as Second Line Treatment in Patients With Malignant Mesothelioma	Phase 2
Recruiting	`NCT05311709` - Sotorasib in Advanced KRASG12C-mutated Non-small Cell Lung Cancer Patients With Comorbidities	Phase 2
Active, not recruiting	`NCT04396457` - Pembrolizumab Plus Pemetrexed for Elderly Patients With Non-Sq NSCLC With PD-L1 < 50%: CJLSG1901	Phase 2
Recruiting	`NCT06391749` - Clinical Validation of an MCED Test in Symptomatic Populations (K-ACCELERATE)
Not yet recruiting	`NCT03910283` - Leveraging Mindsets to Improve Health & Wellbeing in Patients With Cancer	N/A
Recruiting	`NCT03301493` - Genomic Testing and Resulting Medical Decisions
Completed	`NCT04788147` - Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X)	N/A
Not yet recruiting	`NCT06035731` - Evaluation of the Medical Service by Socio-aesthetics in Oncology	N/A
Recruiting	`NCT03274349` - Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma	N/A
Recruiting	`NCT05830097` - A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT02991677` - Exercise Effect on Chemotherapy-Induced Neuropathic Pain	N/A
Completed	`NCT04971304` - Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars
Recruiting	`NCT04859400` - Influence of a Home-based Nutrition and Exercise Program on Quality of Life of Palliative Cancer Outpatients	N/A
Recruiting	`NCT05948865` - A Phase 1 Study of CPO301 in Adult Patients With Advanced or Metastatic Solid Tumors	Phase 1
Recruiting	`NCT04270890` - Investigation of an Abdominal Compression Device	N/A
Not yet recruiting	`NCT05154474` - Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy
Not yet recruiting	`NCT05857995` - Precision Lung Cancer Survivorship Care Intervention	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.