Clinical trial NCT03667755: Fast Track Recovery Surgery Among Gynecologic Oncology Patients
Official title: Fast Track Recovery Feeding With a Whey Protein Infused Carbohydrate Loading Drink and Early Oral Feeding Among Surgical Gynecologic Oncology Patients: A Pragmatic Opened Labelled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fast Track Recovery Surgery
Keywords: pre-operation whey protein infused carbohydrate loading
early oral feeding post-operation
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-12
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: opened labelled randomised trial. Participants will be randomly divided into control \& intervention group during admission to hospital using random numbers. Participants were randomized into two groups: the carbohydrate-protein (CHO-P) group and control (CO) group. Participants were given a specific drink to their group on the evening prior to surgery and three hours before operation. The CHO-P group received 474ml (evening drink) or 237ml (3hours prior to operation drink) of a solution contain 14% whey protein, 86% carbohydrates and 0% lipids and the CO group nil-by-mouth at 12 midnight day of operation. All participants fasted for solids for 6 hours from the operation.

Detailed description: Candidates will attend Multidisciplinary Clinic (MDC) as appointment date for examination then they will get surgery appointment (admit to ward) 7-14 days after MDC date. Eligible patients will be identified from name list available in the electronic medical record. Selection of patient will be done by assigned research team member then she will approach and inform with study procedures to all potential candidates (selected based on inclusion and exclusion criteria) while they attend MDC during study period. Participants will be randomized into two groups: the carbohydrate-protein (CHO-P) group and conventional (CO) group during admission to hospital via random numbers which are issued by computer program. For the concepts of the CONSORT flow diagram are followed \[50\]. The Patient Information Consent Form will be given to identify eligible subjects who agreed to be recruited in the study. Subjects are allowed to bring back consent form if she keen to seek advice from family member.

Carbohydrate-protein group: Participants will attend dietitian clinic to have anthropometry \& dietary assessment on the same day of admission (before admission). Subjects are given a specific drink to their group on the evening prior to surgery and three hours before operation. The CHO-P group received 474ml (evening drink) or 237ml (3 hours prior to operation drink) of a lactose-free clear tea-colour fruit flavoured fluid contains 14% whey protein, 86% carbohydrates and 0% lipids. Participants fast for solids for 6 hours from the operation. Participants will be given clear fluid (2 packs Resource peach) within 24 hours post-surgery (without present of bowel sound) and reviewed by dietitian. Staff nurse in-charged will monitor anesthetic risk of drinking whey protein and ensure subject to finish specific drinks prior surgery. When they tolerated at least 500ml of clear fluids, they were given a regular solid diet.

Conventional group: Participants will attend dietitian clinic to have anthropometry \& dietary assessment on the same day of admission (before admission). Participants followed conventional operation procedure whereby fasting start 12am until operation. On the first day of post-operation day, participants will be reviewed by gynaecologist and dietitian. They are allowed for clear fluid once there is bowel sound. After tolerated clear fluid, they will proceed for nourishing fluid, then soft diet and they were given a regular solid diet.

On the day of operation and on the first day of post-operative day, blood samples are collected for hemoglobin, renal profile, albumin and C-reactive protein. Biochemical data will be record from electronic medical record. Upon discharge, all participants will be sent to dietitian clinic to assess anthropometry and dietary data.

Eligibility criteria: Inclusion Criteria:

* who diagnosed with Gynecologic Cancer stage 1 to stage 4
* candidates for elective operation treatments
* Malaysian aged more than 18 years old

Exclusion Criteria:

* Not a candidate for elective operation treatments
* Aged \<18 years old
* Diagnosed with Diabetes Mellitus/Chronic Kidney Disease/Heart disease/Chronic liver disease
* Allergy to milk/soy/whey protein
* participate other intervention study

Primary outcomes:
measure: length of post-operative hospital stay
timeFrame: throughout hospitalization (up to 2 weeks)
measure: length of clear fluid toleration
timeFrame: throughout hospitalization (up to 1 week)
measure: length of solid food toleration
timeFrame: throughout hospitalization (up to 2 weeks)
Secondary outcomes:
measure: height
timeFrame: throughout hospitalization (up to 2 weeks)
measure: dietary intake trend during hospitalization
timeFrame: daily energy and protein intake throughout hospitalization (up to 2 weeks)
measure: inflammatory effect
timeFrame: on day of operation (before operation and 12 hours after operation)
measure: post-operative complications
timeFrame: throughout hospitalization (up to 2 weeks)
measure: re-admission
timeFrame: 1 month post-operation
measure: muscle mass
timeFrame: throughout hospitalization (up to 2 weeks)
measure: weight
timeFrame: throughout hospitalization (up to 2 weeks)
measure: Body Mass Index
timeFrame: throughout hospitalization (up to 2 weeks)
measure: handgrip strength
timeFrame: throughout hospitalization (up to 2 weeks)
Other outcomes:
Locations:
city: Putrajaya
country: Malaysia
facility: National Cancer Institute
state: Wilayah Persekutuan Putrajaya
Study officials:
References:
citation: Chau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5.
citation: Ho CY, Ibrahim Z, Abu Zaid Z, Mat Daud Z', Md Yusop NB. Fast-track- recovery surgery with a whey-protein-infused carbohydrate-loading drink pre-operatively and early oral feeding post-operatively among surgical gynaecological cancer patients: study protocol of an open-labelled, randomised controlled trial. Trials. 2020 Jun 16;21(1):533. doi: 10.1186/s13063-020-04462-4.