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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04643613
Acronym
Protison
Enrollment
42
Registered
2020-11-25
Start date
2019-03-01
Completion date
2020-03-12
Last updated
2020-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, Cachexia, Nutritional status, Tube feeding, PCNF

Brief 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.

Interventions

DIETARY_SUPPLEMENTProtison cancer nutritional formula (PCNF)

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

Sponsors

Chung Shan Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

None, since treating cancer patients

Intervention model description

Supplementation with the commercial nutritional formula (PCNF; 237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks

Eligibility

Sex/Gender
ALL
Age
55 Years to 84 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Calorie intake12 weeksThe mean value of calorie intake (energy) were significantly increased in PCNF supplemented subjects
Anthropometric parameters12 weeksBMI were markedly improved in PCNF intook subjects
Protein nutritional assessment index or nutritional status12 weeksProtein nutritional assessment index (total protein, pre-albumin , and transferrin) were significantly improved

Secondary

MeasureTime frameDescription
Glycemic indices12 weeksNo significant changes in any of the glycemic indices or lipid profile PCNF groups

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026