Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000218291
Ethics application status
Approved
Date submitted
18/01/2018
Date registered
9/02/2018
Date last updated
23/06/2021
Date data sharing statement initially provided
10/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhanced Recovery After Surgery (ERAS): Pilot Study of Carbohydrate (CHO) Loading Prior to Head and Neck Cancer Surgery
Scientific title
Enhanced Recovery After Surgery (ERAS): Feasibility of Pre-operative Carbohydrate (CHO)Loading in Patients Undergoing Major Head and Neck Cancer Surgery with Free Flap Reconstruction
Secondary ID [1] 293815 0
None
Universal Trial Number (UTN)
U1111-1208-0222
Trial acronym
ERAS in HNC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
head and neck cancer 306229 0
Condition category
Condition code
Cancer 305331 305331 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In patients undergoing major surgery for head and neck cancer involving free flap reconstruction: Eligible patients will be approached for the trial and patient information sheet provided. The patient will be contacted following an indication of willingness to participate. Consent for the study will be signed during or before the pre-admission clinic visit and trial nutrition support product Nutricia PreOp will be provided for patients to self-administer loading dose (4 x 200mL) the night prior to attending for surgery with the remaining (2 x 200mL) to be ingested up to 2 hours prior to anaesthesia. Nutricia PreOp is a low osmolality, fibre and protein-free oral solution which contains carbohydrate polymers maltodextrin to facilitate glucose uptake and gastric emptying. The carbohydrate-rich oral solution provides 0.5kcal/mL and 12.5g CHO; 0g protein; 0g fat per 100mL with the study protocol as follow.
Loading Dose (night before surgery): 800mL (400kcal, 100g CHO)
Final Dose (2 hours prior to surgery): 400mL (200kal, 50g CHO)
TOTAL: 1200mL (600kcal, 150g CHO)
Adherence will be monitored by an intake diary.
Standard care is per surgeon's instructions, typically fasting/nil by mouth for 4-6 hours prior to surgery.
Intervention code [1] 300067 0
Treatment: Other
Comparator / control treatment
A prospective cohort study will examine the feasibility of pre-operative CHO-loading. An initial 25 patients receiving standard care will be followed sequentially to capture nutrition and surgical outcomes data on patients receiving standard care.
Standard care is per surgeon's instructions, typically fasting/nil by mouth for 4-6 hours prior to surgery.
Control group
Active

Outcomes
Primary outcome [1] 304487 0
The primary outcome of the study is the safety and tolerability of pre-operative CHO loading.
Tolerability will be determined by a visual analogue scale whereby patient-reported wellbeing measures eg thirst, hunger, anxiety, nausea, fatigue, pain etc will be captured.
Safety will be determined by presence/absence of adverse events. Every endeavour will be made through careful selection of eligibility/ineligibility criteria, potential adverse events may be nausea, vomiting, aspiration and hyperglycaemia which will be captured.
Timepoint [1] 304487 0
Day of Surgery -1, Days 1, 7, 28 Post-op, on Discharge,
Secondary outcome [1] 342117 0
• Process measures comprise a comprise a composite secondary outcome: Overall, these will capture adherence to perioperative nutrition care elements of ERAS protocols which may include the following
- pre-operative dietetic assessment (Definition: did assessment by a dietitian occur prior to surgery? - yes/no variable)
- minimized fasting procedures (allowing fluids up to 2 hours and solids up to 6 hours prior to anaesthesia) - (Definition: length of time patient NBM prior to surgery as determined by no. hours fasting prior to anaesthesia)
- pre-operative CHO-loading protocol (Definition: for patients receiving the intervention as determined by number of mL CHO-rich solution consumed orally - intake diary will be captured).
- early post-operative nutrition support/oral diet where appropriate within 24 hours (Definition: No of hours post-op nutrition support commenced, whether via oral or enteral route).
- duration of nutrition support (Definition: No. of Days enteral nutrition support ie tube-feeding continued post-op)
Timepoint [1] 342117 0
Day of Surgery -1, Day 1 Post-op and on Discharge
Secondary outcome [2] 342118 0
- nutritional outcomes: nutritional status as measured by PG-SGA.
Scored Patient-Generated Subjective Global Assessment is the recognised gold standard of assessing nutritional status and is validated in an oncology population - score/global rating derived by dietitian assessment of patient history and physical examination of muscle/adipose stores.
Timepoint [2] 342118 0
Day of Surgery -1, Days 1 & & Post-Op, On Discharge
Secondary outcome [3] 342816 0
- nutritional outcomes: weight/% weight change/BMI (a weight derived measure); obtained by stand-on scales if ambulant or bed scales where available for non-ambulant patients.
Timepoint [3] 342816 0
Day of Surgery, Day 7 Post-op, On Discharge
Secondary outcome [4] 342817 0
- biochemical parameters - blood glucose levels; obtained by routine blood tests
Timepoint [4] 342817 0
Day of Surgery, Days 1, & 7 Post-op, On Discharge
Secondary outcome [5] 342818 0
- biochemical parameters ( electrolytes including K+, Mg2+, PO43-); obtained by routine blood tests
Timepoint [5] 342818 0
Day of Surgery, Days 1 & 7 Post-op, On Discharge
Secondary outcome [6] 342819 0
- biochemical parameters - immune and protein status as measured by total lymphocyte count and albumin; obtained via routine blood tests
Timepoint [6] 342819 0
Day of Surgery, Days 1 & 7 Post-Op, On Discharge
Secondary outcome [7] 342820 0
- surgical outcomes - complications (including unplanned return to theatre) as recorded with routine quality monitoring within the head and neck surgical service
Timepoint [7] 342820 0
On Discharge
Secondary outcome [8] 342821 0
- surgical outcomes - 28 day mortality as obtained via routine quality monitoring within the head and neck surgical service.
Timepoint [8] 342821 0
Day 28 Post-op
Secondary outcome [9] 342822 0
- system level impact (length of stay); as recorded by routine hospital administration systems
Timepoint [9] 342822 0
On Discharge

Eligibility
Key inclusion criteria
- Adult patients >18 years undergoing major surgery with free flap reconstruction for head and neck cancer
- Able to speak adequate English to understand patient information sheet and give informed consent
- Willingness to participate in the proposed research
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients at high risk of refeeding syndrome as determined by pre-admission clinic dietitian assessment visit
- Patients with dysphagia requiring thickened fluids
- Patients with diabetes requiring insulin

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
A prospective cohort study will examine the feasibility of pre-operative CHO-loading. An initial 25 patients receiving standard care will be followed sequentially to capture nutrition and surgical outcomes data on patients receiving standard care. A second cohort of 25 patients who will receive the pilot intervention of pre-operative CHO-loading.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Distributions of continuous variables will be checked for normality. Normally distributed variables will undergo parametric analyses while non-normally distributed data will be analysed using non-parametric methods or undergo transformation to normalise data distribution. Differences in continuous data collected for both cohorts will be determined via independent group t-tests while categorical data will be analysed by Chi-squared tests. Analysis will control for significant covariates using random effects modelling. Statistical significance will be assumed at the conventional P<0.05 level (two-tailed).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298428 0
Charities/Societies/Foundations
Name [1] 298428 0
Australia and New Zealand Head and Neck Cancer Society Research Foundation
Country [1] 298428 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
P O Box M30
Missenden Road NSW 2050
Country
Australia
Secondary sponsor category [1] 297779 0
None
Name [1] 297779 0
Address [1] 297779 0
Country [1] 297779 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299425 0
Royal Prince Alfred Hospital, Sydney Local Health District
Ethics committee address [1] 299425 0
Ethics committee country [1] 299425 0
Australia
Date submitted for ethics approval [1] 299425 0
05/03/2018
Approval date [1] 299425 0
23/04/2018
Ethics approval number [1] 299425 0
Protocol No 18-0079 HREC/18/RPAH/103

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80358 0
Ms Merran Findlay
Address 80358 0
C/o Cancer Nursing Research Unit
Level 6, Chris O'Brien Lifehouse
Missenden Rd
CAMPERDOWN NSW 2050
Country 80358 0
Australia
Phone 80358 0
+61 0411779420
Fax 80358 0
Email 80358 0
[email protected]
Contact person for public queries
Name 80359 0
Merran Findlay
Address 80359 0
C/o Cancer Nursing Research Unit
Level 6, Chris O'Brien Lifehouse
Missenden Rd
CAMPERDOWN NSW 2050
Country 80359 0
Australia
Phone 80359 0
+61 0411779420
Fax 80359 0
Email 80359 0
[email protected]
Contact person for scientific queries
Name 80360 0
Merran Findlay
Address 80360 0
C/o Cancer Nursing Research Unit
Level 6, Chris O'Brien Lifehouse
Missenden Rd
CAMPERDOWN NSW 2050
Country 80360 0
Australia
Phone 80360 0
+61 0411779420
Fax 80360 0
Email 80360 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
non-identifiable data only will be collected


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1018Informed consent form    374325-(Uploaded-10-01-2019-07-55-36)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.