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

NCT ID: NCT04643613

Last Updated: 2020-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-03-12

Brief Summary

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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

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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

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Cancer

Keywords

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Cancer Cachexia Nutritional status Tube feeding PCNF

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

None, since treating cancer patients

Study Groups

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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).

Group Type EXPERIMENTAL

Protison cancer nutritional formula (PCNF)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Protison cancer nutritional formula (PCNF)

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Protison

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chin Kun Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chin-Kun Wang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

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Chung Shan Medical University

Taichung, Taichung, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CS17106

Identifier Type: -

Identifier Source: org_study_id