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

Cancer Clinical Trial

— Protison  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04643613
• Other study ID #: CS17106
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 12, 2020

Study information

• Verified date: November 2020
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 12, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 84 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Dietary Supplement:
• Protison cancer nutritional formula (PCNF)
PCNF (237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung city	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calorie intake	The mean value of calorie intake (energy) were significantly increased in PCNF supplemented subjects	12 weeks
Primary	Anthropometric parameters	BMI were markedly improved in PCNF intook subjects	12 weeks
Primary	Protein nutritional assessment index or nutritional status	Protein nutritional assessment index (total protein, pre-albumin , and transferrin) were significantly improved	12 weeks
Secondary	Glycemic indices	No significant changes in any of the glycemic indices or lipid profile PCNF groups	12 weeks