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
Phase: NA
Conditions: Fast Track Recovery Surgery
Sponsor: Universiti Putra Malaysia

FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
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Study Protocol 
 
FAST 
TRACK 
RECOVERY 
WITH 
A 
WHEY 
PROTEIN 
INFUSED 
CARBOHYDRATE LOADING DRINK AMONG SURGICAL GYNECOLOGIC 
ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
 
NMRR Research ID:  
NMRR-17-1070-36021 (II R) 
 
Protocol number, version number and date: 
FTRSG09052017, version 3, 27 September 2017 
 
Name and Institution of Principal investigator: 
Pn. Ho Chiou Yi, National Cancer Institute, Putrajaya 
 
Name and Institution of Co-Investigators: 
Dr. Jamil Omar, National Cancer Institute, Putrajaya 
Dr. Norazzam, National Cancer Institute 
Dr. Zuriati Binti Ibrahim, lecturer Universiti Putra Malaysia 
Dr. Zalina Binti Abu Zaid, lecturer Universiti Putra Malaysia 
Dr. Zulfitri 'Azuan Bin Mat Daud, lecturer Universiti Putra Malaysia 
Dr. Nor Baizura Binti Md Yusop, lecturer Universiti Putra Malaysia 
Dr. Nor Azlin Binti Dahlan, National Cancer Institute 
Dr. Azilah Binti Abdul Aziz, National Cancer Institute 
 
Name and address of Sponsor: 
National Cancer Institute, Ministry of Health Malaysia, Aras 6, No.4, Jln P7, Presint 7, 
62250 Putrajaya 
 
Study site/s: 
Surgical wards of National Cancer Institute. 
 
 

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List of Abbreviations 
 
NCR 
National Cancer Registry 
BMI 
Body Mass Index 
IKN 
Institut Kanser Negara 
LOS 
Length of Hospital Stay 
PG-SGA 
Patient Generated Subject Global Assessment 
aPG-SGA 
Abridge Patient Generated Subject Global Assessment 
Hb 
Hemoglobin 
BFM 
Body Fat Mass 
Alb 
Albumin 
CRP 
C-Reactive Protein 
QoL 
Quality of life 
FTR 
Fast Track Recovery 
CO 
Control group 
CHO-P 
Carbohydrate-whey protein 

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Research Synopsis 
 
Study title 
Fast Track Recovery With A Whey Protein Infused Carbohydrate Loading 
Drink Among Surgical Gynecologic Oncology Patients: A Pragmatic 
Opened Labeled Trial 
Study 
Population 
All patients who has been diagnosed with gynecologic oncology and 
undergoing surgery treatment at National Cancer Institute, Putrajaya. 
Study Design 
Pragmatic opened labeled 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 conventional (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.  
General 
Objective 
To determine the impact of fast track recovery feeding with a whey protein 
plus carbohydrate drink in Surgical Gynecologic Oncology Patient in 
National Cancer Institute 
Specific 
Objectives 
a. To compare post-operation outcome between CHO-P group and 
conventional group. 
b. To compare anthropometric, biochemical and functional data 
between CHO-P group and conventional group 
c. To determine relationship between fast track recovery feeding with 
a whey protein plus carbohydrate drink and post-operative outcome  
Study 
hypothesis  
This hypothesis predicts there is improvement in post-operation outcome of 
intervention group if compare with control group of surgical gynecologic 
oncology patients undergoing surgery treatment in National Cancer 
Institute 
Primary 
Outcome  
Length of hospital stay, length of clear fluid toleration, length of solid food 
toleration, length of flatus, length of bowel open 
Secondary 
outcome 
Weight, fat percentage, muscle mass, PG-SGA, CRP, Albumin, handgrip 
strength 
Sample Size 
106 subjects 
Study 
Duration 
14 months 

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INTRODUCTION  
 
Cancers is group of diseases which involve growth of abnormal cells. Normally, cells 
grow, divide and then die. Sometimes, cells mutate. They begin to grow and divide more 
quickly than normal cells. Rather than dying, these abnormal cells clump together to form 
tumors. Gynecologic oncology is a specialised field of medicine that focuses on cancers 
of the female reproductive system, including ovarian cancer, uterine cancer, vaginal 
cancer, cervical cancer, and vulvas cancer (Disaia et al. 2017).Gynecological Cancer is 
cancers that effect woman’s reproductive system. Other types of gynecological cancers 
include fallopian tube cancer and placenta cancer (a pregnancy-related cancer) (Disaia et 
al. 2017). 
 
In 2009, 16,437 Australians females lived with Gynecological Cancer, where 
4919 new cases of Gynecological Cancer were diagnosed in year 2011. Gynecological 
Cancer had become the 3rd most commonly diagnosed cancer among females in 
Australia (Australian Institute of Health and Welfare 2014). Global Cancer Statistics 
(2012) shows that most common diagnosed cancer in females is cervix uteri besides 
stomach and colorectal cancer and become 3rd leading cause of death in females in less 
developed countries with 90% of cervical cancer death occurred in developing parts of 
the world. National Cancer Registry Report (2014), Cervix Uteri and Ovary cancer were 
in 10 most leading cancer and in 5 most common cancers in Malaysian females from year 
2007 to 2011. There were a total of 847 cases of cervix cancer diagnosed in 2007 
registered at National Cancer Registry (NCR). The incidence rate of cervical cancer 
increased after 30 years old and peaks at ages 65-69 years. When we compared among 
the major races, Indian women had the highest incidence for cervical cancer followed by 
Chinese and Malay. 45% of females at the point of first diagnosis with cervical cancer 
were already at stage 3 and 4.  
 
Cancer cells alter energy metabolism which increase resting energy expenditure 
and increase metabolism of sugar, protein and lipid. Cancer patients including 
gynecological cancer patients’ high risk being malnourished before start on any 
treatment. Nutrition requirement for surgery is higher if compared with normal 
requirement in order to support speedy recovery. For patient who went for surgery 
treatment, length of hospital stay (LOS) of patient after surgery may be affected impaired 
by nutritional status of a patient pre and post-operation. In a cohort study done in 
Australia among 157 Gyneacological Cancer (GC) patients, the data shows that 
malnutrition, low QoL scores and being diagnosed with advanced ovarian cancer are the 
major determinants of LOS amongst GC patients. Intervention addressing malnutrition 
and poor QoL may shorten LOS in GC patients (Laky et a. 2010). LOS has become 
surrogate marker for patient’s well-being during hospital treatment and identifying 

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pretreatment factors associated with LOS in surgical patients may enable early 
intervention in order to reduce postoperative LOS (Lay et al. 2010; Caro et al. 2007). 
Cancer and its treatment result in severe biochemical and physiological alterations 
associated with a deterioration of QoL (Maria et al. 2007). 
 
Like other cancers, first step of gynecological cancer management includes cancer 
diagnosis where clinical and pathological assessments taking place. Once a diagnosis and 
cancer stage is confirmed, oncologists determine treatment options and prognosis and to 
apply the appropriate research treatment protocols. The primary modalities of cancer 
treatment are surgery, chemotherapy and radiotherapy; these may be used alone or in 
combination (Feig et al. 1998). For those cancers which are well margined and operable, 
surgery is first treatments for gynecological cancer (Vetto et al. 1999).  
 
Surgery, a like injury, causes skeletal muscle tissue to be broken down in order to 
release amino acids. These amino acids are transported to the wound to promote wound 
healing. Anabolism, where increased protein synthesis to repair the damaged cells as well 
as new blood vessels, requires protein. Optimum nutritional status peri-operation can 
speed up wound healing, improve immunity and ensure the better post-surgery outcome. 
Other than calories and carbohydrate, protein is crucial for post-surgery recovery and 
promotes anabolism, slows down muscle catabolism and decreases the inflammatory 
phase (Averd et al. 2017). Source of whey protein includes legume, dairy products and 
meat. Whey protein is a high quality protein that is easier to be digested and stimulates 
muscle protein synthesis if compared to casein. These effects may be due to the high 
degree of branched-chain amino acids in whey protein which directly stimulates the early 
cellular process involved in protein synthesis called initiation translation (Kimball et al. 
2002). However, some people who are allergic to milk may be specifically allergic to 
whey protein. In moderate doses, whey protein does not typically cause any adverse 
events but consuming very high doses can cause stomach pains, cramps, reduced 
appetite, nausea, headache and fatigue (Vonk et al. 2003). 
 
Conventional feeding strategy for pre- and post-operation whereby prolonged 
fasting or rest for both the patient and the gastrointestinal tract will delay the recovery of 
patients since the organic response to surgical trauma is enhanced by prolonged period of 
fasting. Inadequate oral intake due to delayed oral feeding caused depletion of nutrient 
storage in patient’s body. This is because of utilization of energy which converted from 
protein source of body (muscle). This metabolism process is called catabolism. Patients 
experienced weight loss and muscle mass loss post-operatively (Balayla et al. 2004; 
Balayla et al. 2005).  
 

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Conventional surgery approach was questioned by professor of surgery, Henrik 
Kehket (1999). Hence, Kehket et al. (1999) developed multimodal perioperative protocol, 
named Enhanced Recovery After Surgery or Fast Track Recovery Surgery protocol. As a 
key of fast track recovery (FTR) programs also include a metabolic strategy to reduce 
perioperative stress and improve outcomes. Nutrition intervention post operation is 
importance. Studies of FTR program in gynecology surgery have shown that such 
programs significantly reduce length of hospital stay and consequently have positive 
economic benefits without increasing readmission and complication rates. To achieve 
these goals, FTR programs focus primarily on reducing perioperative stress, achieving 
satisfactory pain control, resumption of normal gastrointestinal function and early 
mobilization (Balayla et al. 2004; Balayla et al. 2005; Obermair et al. 2017; Ester et al. 
2016; Averd et al. 2017).  
 
1.2 Problem statement  
 
While early oral feeding is preferred mode of nutrition, avoidance of any 
nutritional support therapy bears the risk of underfeeding during postoperative course 
after major surgery. To abbreviate preoperative fasting, beverage containing 
carbohydrates have been used and recommended in FTR program. Formula containing 
protein on top of carbohydrate-enriched drink proposed to improve post-operative muscle 
strength, reduce fatigue, anxiety and discomfort as well as lowering the endocrine-
metabolic response to trauma. Whey protein contains a high level of essential amino 
acids especially branch-chain amino acids. These amino acids are rapidly used by skeletal 
muscle during stress and highly stimulate protein synthesis. Whey protein has a high 
degree of digestibility and rapid absorption in the small bowel. No study so far has aimed 
to examine the benefits of whey protein in the composition pre-operative and post-
operative drinks among surgical gynecologic oncology patients.  
 
Research Questions: 
 
1. What are the nutritional status (anthropometry, dietary intake, muscle mass, 
handgrip strength and biochemical data such as CRP, serum albumin and 
hemoglobin level) in surgical gynecologic oncology patient in National Cancer 
Institute? 
2. What are the post-operative outcomes (length of bowel function, length of solid 
food toleration and length of stay) in surgical gynecologic oncology patient in 
National Cancer Institute? 
3. What are the differences in post-operation outcome between CHO-P group and 
control group? 
4. Is there any relationship between fast track recovery feeding with a whey protein 
plus carbohydrate drink and post-operative outcome? 
 

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1.3 Objective 
 
1.3.1 General Objective 
 
To determine the impact of fast track recovery feeding with a whey protein plus 
carbohydrate loading drink in Surgical Gynecologic Oncology Patient in National Cancer 
Institute 
1.3.2 
Specific objective 
 
a. To compare post-operation outcome between CHO-P group and conventional 
group. 
b. To compare anthropometric, biochemical and functional data between CHO-P 
group and conventional group 
c. To determine relationship between fast track recovery feeding with a whey 
protein plus carbohydrate drink and post-operative outcome 
 
1.4 Null Hypothesis 
 
1. There is no difference in post-operation outcome between CHO-P group and 
conventional group 
2. There is no relationship between fast track recovery feeding with a whey protein 
infused carbohydrate loading drink and post-operative outcome 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Conceptual Framework 
 
Methodology 
 
2.1 Study Design  
 
Pragmatic opened label trial to investigate the impact of fast track recovery feeding with 
whey protein plus carbohydrate drink on surgical gynecologic oncology patients in 
National Cancer Institute.This study will focus on impact towards post-operative 
outcome when whey protein contained pre-operative drink is taken in current standard 
operating procedure in managing surgical gynecologic oncology patients  
 
2.2 Study Period 
 
Recruitment and intervention period is  months, 1st September 2017 to 31st October 2018. 
 
2.3 Study Population 
 
All surgical gynecology patients receiving surgery treatments in National Cancer 
Institute, Putrajaya 
 
 Inclusion criteria 
a. Those who diagnosed with Gynecologic Cancer stage 1 to stage 4  
b. Candidates for elective operation treatments 

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c. Malaysian who aged more than 18 years old  
 
 Exclusion Criteria 
a. Not a candidate for elective operation treatments 
b. Aged <18 years old  
c. Diagnosed with Diabetes Mellitus/Chronic Kidney Disease/Cardiovascular 
disease/Chronic liver disease 
d. Not able to provide informed consent 
e. Allergy to milk/soy/whey protein 
 
2.4 Sample Size   
 
 
 
Sample size estimation was calculated using two population means formulae48. Prior data 
indicate that the mean hospital stay of the control group was 9 (standard deviation = 6.5) 
and the mean of intervention group was 5.6 (standard deviation = 2.35)51. Thus, a 
minimum sample size of 33 samples per group to be able to reject the null hypothesis 
with probability (power) 0.8. The Type I error probability associated with this test of this 
null hypothesis is 0.05. The independent t-test statistic will be used to evaluate this null 
hypothesis. With an additional of 30% dropout rate, the sample size is 53 samples per 
group.  
 
 
 
 
 
 
 
 
 
 
 
 

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2.5 Withdrawal Criteria   
 
Subjects may be withdrawn if the investigator deems that it is detrimental or risky for the 
subject to continue. Subjects also can withdrawal themselves in the middle of this study 
without any reason. Withdrawn subjects will not be replaced. 
 
2.6 Study Tools and Parameters  
 
All parameters and variable data will be collected throughout monitoring period and will 
be recorded in Data Collection Form and aPG-SGA Scoring Sheet.  
 
Patient Generated Subjective Global Assessment (PG-SGA) is a nutritional 
assessment tool that can identify risk of malnutrition among cancer patients.  It includes 
more nutritional symptoms than the one in SGA sheets, short term weight loss and 
numerical scoring which may reflect clinical changes over time [27]. PG-SGA component 
contain first four parts questionnaires reflecting history of weight and weight lost, food 
intake, NIS and functional ability that must be filled by patient him or herself. The next 
part of PG-SGA need to be filled by professionals contains assessment of metabolic 
demands, nutrition and disease requirement and physical exam. Abridge PG-SGA or 
aPG-SGA used only the first four parts questionnaire of original PG-SGA that are prove 
to be sufficient to be used as a useful tool for early detection and predicting outcome of 
cancer cachexia as shown in a cohort study with advanced cancer patients [28]. This study 
shows that a high score of aPG-SGA is significantly associated with lower Hb level, 
increased WBC Count, decreased anthropometry and physical measurement such as BMI, 
BFM and Handgrip Strength, a dose reduction in chemotherapy and increased mortality 
[28].  
 
Valid measurement tools are scheduled calibrated Tanita Total Body Composition 
Analyser model SC 300 which can provide body weight in kg (up to 0.1kg), fat 
percentage (up to 0.1%), total muscle mass (up to 0.1kg). Subject is requested to have 
minimal clothing, empty pocket and stand up-right with bare foot on metal plate of scale. 
Scheduled calibrated SECA Height Measurement (up to 0.1cm) is used to measured 
height. Subject needs to be bare foot, stand up-right and face front while measuring. 
 
Handgrip strength is measured on the non-dominant hand using Jamar hand 
dynamometer (Fred Sammons Inc, Burr Ridge, Illinois, USA). Handgrip strength as a 
surrogate marker for muscle strength in patients with cancer has been well documented 
elsewhere. Subjects sit with their shoulder adducted and neutrally rotated, elbow flexed at 
90º, forearm in neutral position, and standard verbal instructions are given to the subjects 

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to squeeze the dynamometer as hard as possible for three times after an interval of 5 
seconds in between grips. Average of three successive attempts is used as the final result. 
 
The variables that being collected in the Data Collection Form are:- 
1. Socio-Demographic 
a) Age 
b) Ethnic Group 
c) Education Level 
d) Occupation 
2. Pre-operative data 
a) Anthropometric Data: Weight, Height, Muscle mass 
b) aPG- SGA Scoring 
c) Diet Recall via Dietary Assessment Sheet 
d) Handgrip strength 
e) Biochemical data: Hemoglobin (Hb), C-reactive protein and Albumin (Alb) 
3. Post-operative Outcome 
a) Length of Hospital Stay 
b) Length of bowel function 
c) Length of solid food toleration 
 
2.7 Study Flow 
 
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 

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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.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Flow Chart of Research Activities  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Post operative assessment and management 
whereby nil by mouth until bowel sound, 
passage of stool or flatus and subjective 
sensations of hunger were present the diet 
transition fashion 
Screening of patient in MDC, IKN 
Start 
Screening of patient will 
be 
done 
based 
on 
inclusion and exclusion 
criteria. 
Conventional group (CO) 
Intervention Group (FTR) 
   Admission 2-3 days prior surgery& 
assessment in diet clinic before admission 
 
Randomized sampling 
Solid food (High Protein High Calories diet)  
during dinner evening before surgery 
Surgery  
After surgery, subjects will be given specific 
drink on the first post-operation day. When 
they tolerated at least 500ml of specific 
drink, they were given a regular solid diet. 
 
Upon discharged, subjects will be sent to diet clinic to assess 
anthropometric & dietary data 
Discharge home 
- 
474ml specific drink as evening drink 
- 
237ml specific drink 3 hours before 
surgery 
Nil-by-mouth 12am onwards  
   Admission 2-3 days prior surgery& 
assessment in diet clinic before admission 
 
Solid food (High Protein High Calories diet) 
6 hours before surgery 
Surgery  
End  
 
*Collection data will be collected prior to 
treatment and through study period. 

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2.8 Study Duration and Timeline 
 
 
2017 
2018 
 
FEB 
MAR 
APR 
MAY 
JUNE JULY 
AUG 
SEPT 
OCT 
NOV 
DEC 
JAN- 
SEPT 
OCT 
NOV 
DEC 
Literature review 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Draft proposal & 
other documents 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NMRR application 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Modification 
on 
study proposal 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study initiation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection and 
QC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data entry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data cleaning 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Report writing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Presentation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The participation duration for each subject is minimum 1 week until patient is discharged  

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3.10 Statistical Analysis Plan 
 
Energy and macronutrient from diet recall will be analyzed by Axxya system program 
Nutritionist Pro. This is diet analysis and nutrition food label software. Food in diet recall 
is entered into system then system will analyze and show total energy, macronutrients 
and micronutrient intake in kilocalories, gram and microgram. 
 
"The analyses will be performed using IBM SPSS Statistics for Windows 
(Version 22.0. Armonk, NY: IBM Corp.). Descriptive statistics will be utilized for 
selected variables. The results will be presented as frequencies and percentage for 
Categorical Data. Numerical Data which is normally distributed will be presented as 
mean and standard deviation while median and interquartile range will be presented for 
Numerical Data which is not normally distributed.  
 
Comparing Numerical Data which is normally distributed between two groups 
will be analyzed using the Independent t-test while Mann-Whitney test will be used if not 
normally distributed. Pearson's Chi-square test for Independence will be used to study 
association between Categorical Data and Categorical Data while Fisher's exact test will 
be used if assumptions of Pearson's Chi-square test for Independence are not met. 
Multiple logistic regressions will be used to study association between risk factors 
(Numerical Data/Categorical Data) and outcomes (Categorical Data). All probability 
values will be used two-sided and a level of significance of less than 0.05 (p-value < 
0.05) will be considered as statistically significant (Lang & Secic, 2006). 
 
The aim of a clinical trial is to make a calculated judgement about the likely clinical 
effectiveness results that would be seen if the treatments tested were to be used for all 
suitable patients.  The eligibility criteria for a patient entering a clinical trial should 
ensure that they are representative of patients suitable for the treatments being tested and 
compared.  In a randomised trial, the set of all randomised patients is known as the 
‘intention to treat population’, or the ITT population.  This clinical trial study population 
is intended to represent suitable patients and to be reflective of what might be seen if the 
treatment was used in clinical practice. Therefore the ITT population should normally be 
the basis for inferences about the effectiveness of the treatments. 
 
The eligibility criteria for the ITT population and treatments they receive will be 
clearly defined in the study protocol but in practice not everything goes perfectly to plan. 
Therefore, we need to plan ahead for the inconsistencies that can occur, for example, 
because of human error, and consider how we deal with them statistically. 
 

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One deviation from the protocol that is often experienced is when the allocated treatment 
is not actually received by all randomised patients; sometimes patients receive the wrong 
treatment or incomplete treatment.  These things can, however, also happen to patients in 
clinical practice so they should not result in patients’ exclusion from the evaluation made 
on the ITT population.   For this same reason, patients should be analysed according to 
their planned (intended) treatment and not the actual treatment they received.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
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FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
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GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
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(12th edition). British Journal of Haematology, 2017, 178, 652. doi: 10.1111/bjh.14872  
 
Australian Institute of Health and Welfare 2014. Cancer in Australia: an overview, 2014. 
Cancer series no. 78. Cat. No. CAN 75. Canberra: AIHW. 
 
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Siegei, Jacques Ferlay, JoannieLortet-Tieulaent, AhmedinJemal, CA: A cancer Jurnal for 
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Lippincott Williams & Wilkins Publishers 
 
Laky, Brenda and Janda, Monika and Kondalsamy-Chennakesavan, Srinivas and 
Cleghorn, Geoffrey and Obermair, Andreas (2010) Pretreatment malnutrition ans quality 
of life-association with prolonged length of hospital stay among patients with 
gynaecological cancer: A cohort Study. BMC Cancer, 10(1).pp.232-237 
 
Marin Caro, Monica Maria, Laviano, Alessandro Pichard, Claude. Impact of Nutrition on 
QoL during Ca: Current Opinion in Clinical Nutrition and Metabolic Care, July 2007. 
Vol 10-issue 4.p480-487 
 
Nutritional Intervention &QoL in adult Oncology patient. Monica Maria, Marin Caro, 
Alessandro Laviano, Claude Pichard. Clinical Nutrition, June 2007. Vol 26 Issue 3. 
P.289-301. 
 
Arved et al. ESPEN guideline: Clinical nutrition in surgery.Clinical nutrition (2017), 
http://dx.doi.org/10.1016/j.clnu.2017.02.013 
 
Kimball SR, Farrell PA, Jefferson LS: Invited Review: Role of insulin in translational 
control of protein synthesis in skeletal muscle by amino acids or exercise. J ApplPhysiol 
2002, 93(3):1168-1180. 
Vonk, R. J., Priebe, M. G., Koetse, H. A., Stellaard, F., Lenoir-Wijnkoop, I., Antoine, J. 
M., Zhong, Y., & Huang, C. Y. (2003). Lactose intolerance: analysis of underlying factor. 
European 
Journal 
of 
Clinical 
Investigation, 
33(1), 
70-75. 
http://dx.doi.org/10.1046/j.1365-2362.2003.01099.x. PMid:12492455. 
 
Jacques Balayla et al. Randomized clinical trial of the effects of preoperative and 
postoperative oral nutritional supplements on clinical course and cost of care. British 
Journal of Surgery 2004; 91: 983-990 

FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
22 
 
Jacques Balayla et al. Early Versus Delayed postoperative feeding after major 
gynaecologicalcurgery and its effects on cliunical outcomes, patient satisfaction and 
length of stay: a randomised controlled trial. J ObstetGynaecol Can 2015; 37(12): 1079-
1085 
 
Andreas Obermair et al. Nutrition interventions in patients with gynaecological cancers 
requiring surgery. Gynecological Oncology 145 (2017) 192-199 
 
Ester et al. A call for new standard of care in perioperative gynecologic oncology 
practice: impact of enhanced recovery after surgery (ERAS) programs. Gynecology 
oncology 141 (2016) 371-378 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
23 
 
Appendix A 
 
 
 

FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
24 
 
Appendix B (a)– Data Collection Form 
 
DIETITIAN CLINIC: pre-operation (on the day of admission)  
BASELINE DATA 
 
DEMOGRAPHIC DATA 
ID 
 
AGE 
 
years 
 
EDUCATION LEVEL 
 
NO 
EDUCATION 
 
PRIMARY 
 
SECONDARY 
 
TERTIARY 
 
 
ETHNIC 
 
MALAY 
 
CHINESE 
 
INDIAN 
 
 
 
 
OCCUPATION 
 
NOT 
WORKING 
 
WORKING 
 
 
 
 
 
 
ANTHROPOMETRY DATA 
HEIGHT 
m 
WEIGHT 
KG 
 
BMI 
Kg/m² 
 
PG-SGA SCORE 
 
TO ATTACHED ABRIDGE PG-SGA SCORE FORM 
MUSCLE MASS  
 
HANDGRIP STRENGTH: 1.             2.              3. 
CLINICAL DATA 
DIAGNOSIS 
 
STAGE OF CANCER 
 
DATE OF PLANNED SURGERY 
 
 
BIOCHEMICAL DATA 
SERUM ALBUMIN 
g/dL 
Hb 
mmol/L 
 
C-REACTIVE PROTEIN  
 
 
NUTRITION ASSESSTMENT 
DIET RECALL 
TOTAL INTAKE: 
E- 
P- 
BFE 
 
MTE 
 
L
E 
 
AT
E 
 
DE 
 
BFP 
 
MTP 
 
L
P 
 
AT
P 
 
DP 
 
SE 
 
DIET RECALL MUST BE RECORDED IN DIETETIC CARE 
NOTES AND ATTACHED TOGETHER WITH THIS FORM. 
SP 
 
DIET PRESCRIPTION 
 
 
 
ONS SUPPLEMENTATION 
PRODUCT 
 
DILUTION 
 
FREQUENCY 
 
DIETITIAN I/C 
 
CHOP: 
 
 
 
 
 
 
 
 
 
 
 

FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
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25 
 
Appendix B (b)– Data Collection Form 
 
PROGRESS IN WARD:  
 
DEMOGRAPHIC DATA 
ID 
AGE 
 
years 
 
ADMISSION 
DATE & TIME 
 
 
Go to Dietitian clinic before admission 
 Yes 
 
PRE-OPERATION 
Date & Time For Evening Drink  
 
TOTAL PACKS FINISHED 
 
Date & Time For 3 Hours Pre-Operation Drink 
 
TOTAL PACK FINISHED 
 
Blood (RP, Alb, Hb & CRP) day before operation 
       Taken (at ward) 
Dextrose  
 
 
POST-OPERATION 
Blood (RP, Alb, Hb & CRP) day 1 operation 
      Taken (at recovery bay, Operation theatre) 
Dextrose  
       Taken (at ward) 
Date & Time To Start Drink (Clear Fluid) 
 
TOTAL TOLERATION: 
          ml 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date & Time To Start Regular/Solid Diet 
 
 
 
Date & Time To Tolerate Regular Diet 
 
Date & Time To Pass Flatus 
 
Date & Time To bowel open 
 
 
DISCHARGE DATE & TIME  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
26 
 
Appendix B (c)– Data Collection Form 
 
DIET CLINIC (OUTPATIENT) – post-operation (upon discharged) 
 
DEMOGRAPHIC DATA 
ID 
AGE 
 
years 
 
ANTHROPOMETRY DATA 
HEIGHT 
m 
WEIGHT 
KG 
 
BMI 
Kg/m² 
 
HANDGRIP STRENGTH 
1.                       3. 
2. 
 
MUSCLE MASS  
 
 
BIOCHEMICAL DATA 
SERUM ALBUMIN 
g/dL 
HB 
mmol/L 
 
CRP 
 
 
NUTRITION ASSESSTMENT 
DIET RECALL 
TOTAL INTAKE: 
E- 
P- 
BFE 
 
MTE 
 
L
E 
 
AT
E 
 
DE 
 
BFP 
 
MTP 
 
L
P 
 
AT
P 
 
DP 
 
SE 
 
DIET RECALL MUST BE RECORDED IN DIETETIC CARE 
NOTES AND ATTACHED TOGETHER WITH THIS FORM. 
SP 
 
DIET PRESCRIPTION 
 
 
 
 
ONS SUPPLEMENTATION 
PRODUCT 
 
DILUTION 
 
FREQUENCY 
 
DIETITIAN I/C 
 
CHOP: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
27 
 
Participant Information Sheet and Informed Consent Form 
(for adult subjects and intervention studies) 
 
1. Title of study:  
 
FAST 
TRACK 
RECOVERY 
WITH 
A 
WHEY 
PROTEIN 
INFUSED 
CARBOHYDRATE LOADING DRINK AMONG SURGICAL GYNECOLOGIC 
ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
 
2. Name of investigator and institution:  
Name and Institution of Principal investigator:  
Ho Chiou Yi, National Cancer Institute, Putrajaya 
 
Name and Institution of Co-Investigators:  
Dr. Jamil Omar, National Cancer Institute, Putrajaya 
Dr. Norazzam, National Cancer Institute 
Dr. Zuriati Binti Ibrahim, Pensyarah Universiti Putra Malaysia 
Dr. Zalina Binti Abu Zaid, Pensyarah Universiti Putra Malaysia 
Dr. Zulfitri 'Azuan Bin Mat Daud, Pensyarah Universiti Putra Malaysia 
Dr. Nor Baizura Binti Md Yusop, Pensyarah Universiti Putra Malaysia 
Dr. Nor Azlin Binti Dahlan, National Cancer Institute 
Dr. Azilah Binti Abdul Aziz, National Cancer Institute 
 
3. Introduction:  
 
This study is a prospective randomized pragmatic opened label trial study. There is 
experimental intervention being administered.  
 
We would like to invite you to take part in our research study because you have 
gynecology cancer. Before you decide we would like you to understand why the research 
is being done and what it would involve for you. One of our team members will go 
through the information sheet with you and answer any questions you have. We’d suggest 
this should take about 5-10 minutes. Ask us if there is anything that is not clear. After you 
are properly satisfied that you understand this study, and that you wish to participate, you 
must sign this informed consent form.  
 
Your participation in this study is voluntary. You do not have to be in this study if you do 
not want to. You may also refuse to answer any questions you do not want to answer. If 
you volunteer to be in this study, you may withdraw from it at any time. If you withdraw, 
any data collected from you up to your withdrawal will still be used for the study. Your 
refusal to participate or withdrawal will not affect any medical or health benefits to which 
you are otherwise entitled. There is no prorated payment for participation in this study. 
 
A total of 106 subjects from multidiscipline outpatient clinic in National Cancer Institute, 
Putrajaya will be participating in this study. The whole study will last about 14 months. 
The participation duration for each subject is minimum 1 week until patient is discharged. 

FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
28 
 
Probability for randomization into group A and group B are the same. If you agree to 
participate in the study, you will be assigned into either group A or B.  
The product used in this study does not contain porcine and bovine ingredient and has 
been certified HALAL by Singapore Authorities. This study has been approved by the 
Medical Research and Ethics Committee, Ministry of Health Malaysia.  
 
4. What is the purpose of the study? 
 
This study is to determine the impact of fast track recovery feeding with a whey protein 
infused carbohydrate drink among surgical gynecologic oncology patients in National 
Cancer Institute  
 
5. What will happen if I decide to take part? 
 
a. In this study, we will collect information on your nutritional status, physical 
function and hospitalization record.  
 
b. At first, we will collect information about your medical condition from your 
medical record at the time of follow up in medical outpatient clinic, including your 
blood laboratory investigations. All blood laboratory investigations are extracted 
from your medical outpatient record and not taken specific to the purpose of this 
study.  
 
c. A dietician will assess your nutritional status in diet clinic. Your nutritional status 
will be assessed using a questionnaire; dietary recall and measurements of your 
height, weight, body fat percentage and handgrips at the arm will be assessed. 
Weight, height and body fat percentage will be measured using a special scale that 
requires you to stand on the scale.  
 
d. Upon admission, you have to attend to diet clinic to assess of your height, weight, 
body fat percentage and handgrips.  
 If you are assigned to group A, you need to be fasting at 12 midnight and only 
allowed to take water till 3 hours before operation.  
 If you are assigned to group B, you are allowed to take solid food as hospital 
served 6 hours before operation. 3 hours before operation, you will be 
provided 1 pack supplement (a lactose-free clear tea-colour fruit flavoured 
fluid contain 14% whey protein, 86% carbohydrates and 0% lipids).  
Upon discharge from ward, you have to attend to diet clinic to assess of your 
weight, body fat percentage and handgrips. 
 
e. After completion of study, continuous treatment (diet intervention & oncological 
treatment) will be given as routine care. Study product will not be continued. But 
high protein nourishing fluid will only be given if indicated (malnutrition) after 
dietary assessment.   
 
 

FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
29 
 
6. What are my responsibilities when taking part in this study? 
 
It is important that you answer all of the questions asked by the study staff honestly and 
completely as well as compliance to diet advice and oral supplement as planned. 
 
7. What are the potential risks and side effects of being in this study? 
 
You may feel slight tired during the measurement of handgrip strength at the arm, which 
will resolve spontaneously after the measurement is completed. During admission to 
ward, branula will be set as routine care & which will cause discomfort.  
 
Others potential risk and side effects of being in this study (group B) is intolerance 
towards whey protein plus carbohydrate drink provided such as nausea, diarrhea or 
vomiting. If such intolerance occurs by the subjects, these steps will be taken into 
measure: 
- 
To substitute with carbohydrate drink only and to ask subjects to withdraw from 
the study 
- 
To stop the prescription of whey protein plus carbohydrate drink and to ask 
subjects to withdraw from the study 
- 
Referral to doctor if necessary 
 
8. What are the benefits of being in this study? 
 
There may or may not be any benefits to you. This study does provide a better 
understanding of the disease/condition studied. It may provide benefit for surgical 
gynecologic oncology patients in the future in terms of development of new dietary 
intervention protocol in cancer patient ongoing for surgery treatment.  
 
9. What if I am injured during this study? 
 
If you are injured as a result of being in this study, you should contact your investigator. 
In the event of a bodily injury or illness directly resulting from the study product or a 
medical procedure required for this study which is very minimal, you will be referred to a 
medical doctor as soon as possible and the expenses involve will be paid by the sponsor. 
The sponsor is not responsible for medical expenses due to pre-existing medical 
conditions, any underlying disease, any ongoing treatment process, your negligence or 
willful misconduct, the negligence or willful misconduct of your investigator or the study 
site or any third parties. You do not lose any of your legal rights to seek compensation by 
signing this form.  
 
10. What are my alternatives if I do not participate in this study? 
 
You do not have to participate in this study to get treatment for your disease or condition. 
Alternative treatments of routine care in dietary interventions post-surgery are available 
in Institut Kanser Negara and most of government hospitals. You always can get diet 
intervention post-surgery and usage of high protein nourishing fluid will be depending on 

FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
30 
 
your daily energy and protein requirement to support post-surgery wound healing and 
optimize nutritional status.  
 
11. Who is funding this research?  
 
This study is funded by Institut Kanser Negara (sponsor).  
 
12. Can the research or my participation be terminated early? 
 
The research officer may due to concerns for your safety, stop the study or participation 
at any time. If the study is stopped early for any reason you will be informed and 
arrangements made for your future care. You may be asked to attend a final follow up 
visit. 
 
13. Will my medical information be kept private? 
 
All your information obtained in this study will be kept and handled in a confidential 
manner, in accordance with applicable laws and/or regulations. Principal investigator and 
co-investigator in this study only are allowed to assess to medical records and data. The 
identification number instead of patient identifiers will be used on subject data sheets. All 
data will be entered into a computer that is password protected. When publishing or 
presenting the results, your identity will not be revealed without your expressed consent. 
Individuals involved in this study and in your medical care, and governmental or 
regulatory authorities may inspect and copy your medical records, where appropriate and 
necessary. 
 
 
With your permission, your family will be informed that ypur participation in 
this study. You will not be informed of study findings. You will be informed if new 
information becomes available relevant to consent. All data of study might be sent to 
overseas for analysis but your identity will not be exposed all the time.  
 
14. Who should I call if I have questions? 
 
If you have any questions about the study or you think you have a study related injury or 
you want information about treatment, please contact the researcher as below:  
 
Ho Chiou Yi 
Dietitian U 41 
Dietetic and Food Service Department 
National Cancer Institute 
03-88923406 
dtho@nci.gov.my 
 
If you have any questions about your rights as a participant in this study, please contact: 
The Secretary, Medical Research & Ethics Committee, Ministry of Health Malaysia, at 
telephone number 03-2287 4032.  

FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED CARBOHYDRATE LOADING DRINK AMONG SURGICAL 
GYNECOLOGIC ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
31 
 
INFORMED CONSENT FORM 
 
Title of Study: FAST TRACK RECOVERY WITH A WHEY PROTEIN INFUSED 
CARBOHYDRATE LOADING DRINK AMONG SURGICAL GYNECOLOGIC 
ONCOLOGY PATIENTS: A PRAGMATIC OPENED LABELED TRIAL 
 
By signing below I confirm the following: 
 
I have been given oral and written information for the above study and have read and 
understood the information given.  
 
I have had sufficient time to consider participation in the study and have had the 
opportunity to ask questions and all my questions have been answered satisfactorily.  
 
I understand that my participation is voluntary and I can at anytime free to withdraw 
from the study without giving a reason and this will in no way affect my future 
treatment. I understand the risks and benefits, and I freely give my informed consent 
to participate under the conditions stated. I understand that I must follow the study 
doctor’s instructions related to my participation in the study. 
 
I understand that study staff and government or regulatory authorities have direct 
access to my medical record in order to make sure that the study is conducted 
correctly and the data are recorded correctly and the data are recorded correctly. All 
personal details will be treated as STRICTLY CONFIDENTIAL.  
 
I will receive a copy of this subject information/ informed consent form signed and 
dated to bring home. 
 
Subject: 
 
Signature: 
 
 
 
 
I/C number: 
 
 
Name:  
 
 
 
 
Date: 
 
 
Investigator conducting informed consent: 
 
Signature: 
 
 
 
 
I/C number: 
 
 
Name:  
 
 
 
 
Date: 
 
 
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