Effect of Nutritional Formula (Protison) on Various Cance... | NCT04643613

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

NCT04643613

Sponsor

Chung Shan Medical University

Status

Completed

Last Update Posted

Nov 25, 2020Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

Cancer

Interventions

Protison cancer nutritional formula (PCNF)

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Sep 1, 2019Actual

Completion Date

Mar 12, 2020Actual

First Submitted Date

Nov 16, 2020

First Submission Date that Met QC Criteria

Nov 19, 2020

First Posted Date

Nov 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2020

Last Update Posted Date

Nov 25, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chin Kun Wang, Professor, Chung Shan Medical UniversityPrincipal Investigator

Lead Sponsor

Chung Shan Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Protison cancer nutritional formula (PCNF)	Dietary Supplement	PCNF (237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks	PCNF

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chin-Kun Wang, Ph.D	Chung Shan Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung Shan Medical University		Taichung	Taichung	40201	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

No, it's confidential

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D002100	Cachexia

Ancestor Terms

ID	Term
D015431	Weight Loss
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided