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NCT Number: NCT04643613

Effect of Nutritional Formula (Protison) on Various Cancer Patients: A Randomized Clinical Trial

Many studies (including ASPEN/ESPEN) have demonstrated that balanced diet formula rich in omega 3 fatty acids (ω-3 FA), fibers, protein as well as mineral, vitamins (trace elements) are essential for cancer patients to improve health status and tolerability of chemotherapy. Hence, the present multi-centered, randomized clinical trial was framed to evaluate the efficacy of ready to use balanced nutritional formula-PCNF (rich in ω-3 FA, fibers, MTC, BCAA, and micro-nutrients), in various cancer patient by checking calorie intake and overall health status through assessing various anthropometric and biochemical parameters especially total proteins, pre-albumin, and transferrin.

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Key information

Age range

55 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, 40201, Taiwan

About this study

Many studies (including ASPEN/ESPEN) have demonstrated that balanced diet formula rich in omega 3 fatty acids (ω-3 FA), fibers, protein as well as mineral, vitamins (trace elements) are essential for cancer patients to improve health status and tolerability of chemotherapy. Hence, oncologic nutritionist strongly recommends cancer patients (with cachexia) to consume a diet rich in protein and dietary fibers along with balanced essential micronutrients like vitamins and minerals (Van Norren et al., 2009; Yeh et al., 2013). From the above statement, it cleared that nutritional support is a crucial aspect of multi-modal cancer care, by improving the overall health status by suppressing various adverse events as well as enhance treatment regimen for a speedy recovery. Hence, the present multi-centered, randomized clinical trial was framed to evaluate the efficacy of ready to use balanced nutritional formula-PCNF (rich in ω-3 FA, fibers, MTC, BCAA, and micro-nutrients), in various cancer patient by checking calorie intake and overall health status through assessing various anthropometric and biochemical parameters especially total proteins, pre-albumin, and transferrin.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • only hospitalized cancer patients with risk of malnutrition and underweight (confirmed with BMI, protein, and pre-albumin level) and must be under NG tube feeding.

Exclusion criteria

  • avoiding cancer patients under critical conditions, with cardiac, renal, and hepatic disorders. Also, heavy smokers, chronic or chain smokers, and pregnant/lactating women were not included.

Treatment and study plan

Protison cancer nutritional formula (PCNF)

Dietary Supplement

PCNF (237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks

Other names: Protison

Primary outcomes

  1. Calorie intake

    Time frame: 12 weeks

    The mean value of calorie intake (energy) were significantly increased in PCNF supplemented subjects

  2. Anthropometric parameters

    Time frame: 12 weeks

    BMI were markedly improved in PCNF intook subjects

  3. Protein nutritional assessment index or nutritional status

    Time frame: 12 weeks

    Protein nutritional assessment index (total protein, pre-albumin , and transferrin) were significantly improved

Secondary outcomes

  1. Glycemic indices

    Time frame: 12 weeks

    No significant changes in any of the glycemic indices or lipid profile PCNF groups

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

Role of Ready to Drink Nutritional Formula (Protison Enriched With ω-3 FA and BCAA) Supplemented by Nasogastric Tube Feeding in Various Cancer Patients: A Randomized Clinical Trial

Acronym: Protison

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 25, 2020
Registry last updated
Nov 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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