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

Chung Shan Medical University

Status: Completed

Conditions: Cancer

Treatments: Dietary Supplement: Protison cancer nutritional formula (PCNF)

Study type: Interventional

Funder types: Other

Identifiers

NCT04643613

CS17106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 55 to 84 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

PCNF

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Protison cancer nutritional formula (PCNF)