NCT04643613

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Chung Shan Medical University · Academic / Other
• Sex: All
• Age: 55 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Protison cancer nutritional formula (PCNF)	PCNF (237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-09-01
• Completion: 2020-03-12
• First posted: 2020-11-25
• Last updated: 2020-11-25

Locations

1 site across 1 country: Taiwan