UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033915
Receipt number R000038679
Scientific Title Fast Track Recovery Feeding with a Whey Protein Infused Carbohydrate drink among Surgical Gynecologic Oncology Patients: A Pragmatic Opened Labeled Trial
Date of disclosure of the study information 2018/09/27
Last modified on 2018/08/27 15:07:40

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Basic information

Public title

Fast Track Recovery Feeding with a Whey Protein Infused Carbohydrate drink among Surgical Gynecologic Oncology Patients: A Pragmatic Opened Labeled Trial

Acronym

Fast Track Recovery Feeding with a Whey Protein Infused Carbohydrate drink among Surgical Gynecologic Oncology Patients: A Pragmatic Opened Labeled Trial

Scientific Title

Fast Track Recovery Feeding with a Whey Protein Infused Carbohydrate drink among Surgical Gynecologic Oncology Patients: A Pragmatic Opened Labeled Trial

Scientific Title:Acronym

Fast Track Recovery Feeding with a Whey Protein Infused Carbohydrate drink among Surgical Gynecologic Oncology Patients: A Pragmatic Opened Labeled Trial

Region

Asia(except Japan)


Condition

Condition

recruiting

Classification by specialty

Surgery in general Obstetrics and Gynecology Not applicable
Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Compare post operative outcome between intervention and control groups

Basic objectives2

Others

Basic objectives -Others

Compare nutritional and functional status between intervention and control groups

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

post-operative outcomes (length of stay, length of clear fluid toleration, length of solid food toleration, length of return of gastrointestinal function)

Key secondary outcomes

weight, muscle mass, dietary intake
(protein & energy), biochemical data (albumin and C reactive protein) & functional data (handgrip strength)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

intervention group
receive carbohydrate loading regime (100g carbohydrate with 18g whey protein aseveining drink night before operation, 50g carbohydrate with 9g whey protein 3hours before operation) and start on early oral feeding post operation

Interventions/Control_2

conventional group
follow conventional procedure: fasting since 12am on operation day and start oral feeding when there is bowel sound.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

diagnosed with gynecologic cancer
candidate for elective surgery
malaysian who aged more than 18 years old

Key exclusion criteria

not a candidate for elective surgery
aged <18years old
diagnosed with diabetic mellitus/chronic kidney disease/heart disease/liver disease
allergy for milk/soy/whey protein
joined other intervention study

Target sample size

106


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Zuriati binti Ibrahim

Organization

Universiti Putra Malaysia

Division name

Dietetic department

Zip code


Address

Universiti Putra Malaysia, 43400 Seri Kembangan, Selangor, Malaysia

TEL

+60199349317

Email

zuriatiib@upm.edu.my


Public contact

Name of contact person

1st name
Middle name
Last name Ho Chiou Yi

Organization

National Cancer Institute

Division name

dietetic department

Zip code


Address

4, Jalan P7, Presint 7, 62250 Putrajaya, Malaysia

TEL

+60127603622

Homepage URL


Email

agneshcy0326@gmail.com


Sponsor or person

Institute

National Cancer Institute
Dietetic department
4, Jalan P7, Presint 7, 62250 Putrajaya, Malaysia

Institute

Department

Personal name



Funding Source

Organization

National Cancer Institute
Dietetic department
4, Jalan P7, Presint 7, 62250 Putrajaya, Malaysia

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NMRR-17-1070-36021 (II R)

Org. issuing International ID_1

Medical Research and Ethics Committee (MREC) Malaysia

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 27 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2017 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry

2018 Year 09 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 27 Day

Last modified on

2018 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038679


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name