Improving nutritional status in cancer patients using NUTRICAN
The Effect of Oral Nutrition Supplement Formulas (ONS) and Diet Counseling on Improvement of Nutritional Status, Knowledge, Attitudes, and Behavior of Cancer Patients
This study is testing whether an oral nutrition supplement called NUTRICAN can help cancer patients at risk of malnutrition improve their nutritional health compared to those who only receive dietary counseling.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kalbe International Pte. Ltd Industry-sponsored |
| Locations | 1 site (Jakarta) |
| Trial ID | NCT06128694 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of an oral nutrition supplement (NUTRICAN) in improving the nutritional status of cancer patients at risk of malnutrition. It employs an open-label randomized controlled trial design, where participants are divided into two groups: one receiving the supplement along with dietary counseling and the other receiving only dietary counseling. The study assesses various outcomes, including knowledge and attitudes towards nutrition, body weight, BMI, hemoglobin, and albumin levels over an 8-week period. Participants are stratified by age and cancer type to ensure balanced groups.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed lung or gynecological cancers who are experiencing malnutrition.
Not a fit: Patients who are pregnant or breastfeeding, or those with certain medical conditions that exclude them from the study, may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this study could significantly enhance the nutritional status and overall health of cancer patients at risk of malnutrition.
How similar studies have performed: Previous studies have shown promising results with similar nutritional interventions in cancer patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Jakarta
- Persahabatan General Hospital — Jakarta, Indonesia (Recruiting)
Study contacts
- Principal investigator: Elisna Syahruddin, Phd.MD — Persahabatan Hospital
- Study coordinator: Sri AP Simanullang, B.Pharm
- Email: sri.simanullang@pharmametriclabs.com
- Phone: +62 81255434018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.