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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Dietary supplement: Protison cancer nutritional formula (PCNF)

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung
    • Taichung city, Taichung, Taiwan, 40201
      • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCNF; Totally 42 cancer patients with poor nutritional status under nasogastric (NG) tube feeding was recruited and administered with the commercial nutritional formula (PCNF; 237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks (84 days).	Dietary supplement: Protison cancer nutritional formula (PCNF); PCNF (237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks; Other Names: Protison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calorie intake	The mean value of calorie intake (energy) were significantly increased in PCNF supplemented subjects	12 weeks
Anthropometric parameters	BMI were markedly improved in PCNF intook subjects	12 weeks
Protein nutritional assessment index or nutritional status	Protein nutritional assessment index (total protein, pre-albumin , and transferrin) were significantly improved	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic indices	No significant changes in any of the glycemic indices or lipid profile PCNF groups	12 weeks

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Investigators: Principal Investigator: Chin-Kun Wang, Ph.D, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): March 12, 2020

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): November 25, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Nutritional status; Cachexia; Tube feeding; PCNF
• Other Study ID Numbers: CS17106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No, it's confidential

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No