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

NCT04643613 | Completed DMC

• 1 other identifier: CS17106
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Cachexia; Nutritional status; Tube feeding; PCNF

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Glycemic indices

  12 weeks

Study Arms (1)

PCNF

EXPERIMENTAL

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)

Interventions

Protison cancer nutritional formula (PCNF) DIETARY_SUPPLEMENT

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

Also known as: Protison

PCNF

Eligibility Criteria

• Age: 55 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Neoplasms; Cachexia

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Chin-Kun Wang, Ph.D

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None, since treating cancer patients
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 25, 2020
• Study Start: March 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: March 12, 2020
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)