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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033915
Receipt No. R000038679
Official scientific title of the study 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

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Basic information
Official scientific title of the study Fast Track Recovery Feeding with a Whey Protein Infused Carbohydrate drink among Surgical Gynecologic Oncology Patients: A Pragmatic Opened Labeled Trial
Title of the study (Brief title) 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 Obsterics 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 Zuriati binti Ibrahim
Organization Universiti Putra Malaysia
Division name Dietetic department
Address Universiti Putra Malaysia, 43400 Seri Kembangan, Selangor, Malaysia
TEL +60199349317
Email zuriatiib@upm.edu.my

Public contact
Name of contact person Ho Chiou Yi
Organization National Cancer Institute
Division name dietetic department
Address 4, Jalan P7, Presint 7, 62250 Putrajaya, Malaysia
TEL +60127603622
Homepage URL
Email agneshcy0326@gmail.com

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

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 27 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.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
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