Effect of NUTRICAN to Improve Nutritional Status in Cancer Patients

NCT06128694 | Unknown Phase 3 DMC

• 1 other identifier: Constatine Study
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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. 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. 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?

Conditions

Malnutrition; Protein; Cancer, Lung; Cancer Cervix

Keywords

malnutrition; oral nutrition supplement; cancer; Nutrican

Outcome Measures

Primary Outcomes (7)

• 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);

  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)

  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).

  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.

  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)

  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.

  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

  8 weeks

Secondary Outcomes (6)

• Calorie intake

  8 weeks

• Protein intake

  8 weeks

• Inflammatory status by CRP

  8 weeks

• Inflammatory status by IL-1

  8 weeks

• Inflammatory status by IL-6

  8 weeks

Study Arms (2)

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

Dietary Supplement: NUTRICAN

Control group

NO INTERVENTION

only received dietary counseling for 8 weeks without ONS supplementation.

Interventions

NUTRICAN DIETARY_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.

ONS (oral nutrition supplement) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kalbe International Pte. Ltd: lead
• Persahabatan Hospital: collaborator

Study Sites (1)

Persahabatan General Hospital

Jakarta, 13230, Indonesia

RECRUITING

MeSH Terms

Conditions

Kwashiorkor; Lung Neoplasms; Uterine Cervical Neoplasms; Malnutrition; Neoplasms

Condition Hierarchy (Ancestors)

Severe Acute Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Elisna Syahruddin, Phd.MD

  Persahabatan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sri AP Simanullang, B.Pharm

CONTACT

+62 81255434018; sri.simanullang@pharmametriclabs.com

Dedyanto H Saputra, MD

CONTACT

+62 81519102333; dedyanto.henky@kalbe.co.id

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 13, 2023
• Study Start: August 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: August 30, 2024
• Last Updated: July 30, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting December 2023
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal. For more information or to submit a request, please contact: dedyanto.henky@kalbe.co.id

Locations

ID (1)