Malnutrition; ProteinPhase 3NCT06128694
Effect of NUTRICAN to Improve Nutritional Status in Cancer Patients
A Phase 3 study testing NUTRICAN in people with Malnutrition; Protein and Cancer, Lung, run by Kalbe International Pte. Ltd at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition; Protein, Cancer, Lung, Cancer Cervix
- What is being tested?
- NUTRICAN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2023to 30 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- Pregnant and breastfeeding, except for female subjects with one of the following criteria:
- Have a history of hysterectomy (surgical removal of the uterus) and/or bilateral oophorectomy (surgical removal of the ovaries).
- Medically confirmed ovarian failure (decreased ovarian function)
- 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)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Persahabatan General Hospital
Jakarta, 13230
Elisna Syahruddin, Prof.PhD,dr, +628179181639, elisna2002@gmail.com
About this study
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
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:
- 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?
- 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?
Read the 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.
- Conditions
- Malnutrition; Protein, Cancer, Lung, Cancer Cervix
- Being tested
- NUTRICAN
- Keywords
- malnutrition, oral nutrition supplement, cancer, Nutrican
- Medical subject headings
- Kwashiorkor, Lung Neoplasms, Uterine Cervical Neoplasms, Malnutrition, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUTRICANDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| ONS (oral nutrition supplement) group | Experimental | 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 Receives: Dietary Supplement: NUTRICAN |
| Control group | No intervention | only received dietary counseling for 8 weeks without ONS supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition consumption knowledge score
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);
Measured: 8 weeks
Nutrition consumption attitude score
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)
Measured: 8 weeks
Nutrition consumption behaviour score
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).
Measured: 8 weeks
Nutritional status by body weight
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.
Measured: 8 weeks
Nutritional status by body mass index
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)
Measured: 8 weeks
Nutritional status by haemoglobin
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.
Measured: 8 weeks
Nutritional status by albumin
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
Measured: 8 weeks
Secondary outcomes (6)
Calorie intake
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.
Measured: 8 weeks
Protein intake
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
Measured: 8 weeks
Inflammatory status by CRP
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.
Measured: 8 weeks
Inflammatory status by IL-1
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.
Measured: 8 weeks
Inflammatory status by IL-6
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.
Measured: 8 weeks
Inflammatory status by TNF-α
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Aug 2023
- Primary completion1 Nov 2023
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition; ProteinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kalbe International Pte. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Persahabatan Hospital
- Responsible party
- Sponsor
- Investigators
- Elisna Syahruddin, Phd.MD, Principal investigator, Persahabatan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128694
- Sponsor's protocol ID
- Constatine Study
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06128694
- Acronym / sponsor ID
- Constatine Study
- Conditions
- Malnutrition; Protein, Cancer, Lung, Cancer Cervix
- Keywords
- malnutrition, oral nutrition supplement, cancer, Nutrican
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Kalbe International Pte. LtdIndustry (pharma, biotech, devices)
- Collaborators
- Persahabatan Hospital
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONS (oral nutrition supplement) group | Experimental | Dietary Supplement: NUTRICANONS 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 |
| Control group | No intervention | –only received dietary counseling for 8 weeks without ONS supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Intervention group subjects are willing to take ONS orally for 8 weeks
Key exclusion criteria (6 listed)
- Pregnant and breastfeeding, except for female subjects with one of the following criteria:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUTRICANPer 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. | Dietary supplement | ONS (oral nutrition supplement) group |
Primary outcome
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);
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)
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).
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.
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)
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.
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
6 secondary outcomes
Calorie intake
Time frame: 8 weeks
Protein intake
Time frame: 8 weeks
Inflammatory status by CRP
Time frame: 8 weeks
Inflammatory status by IL-1
Time frame: 8 weeks
Inflammatory status by IL-6
Time frame: 8 weeks
Inflammatory status by TNF-α
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisna Syahruddin, Phd.MD principal investigator
Persahabatan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NUTRICAN in people with Malnutrition; Protein and Cancer, Lung, run by Kalbe International Pte. Ltd at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sri AP Simanullang, B.Pharm (+62 81255434018, sri.simanullang@pharmametriclabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition consumption knowledge score (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.