Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001017617
Ethics application status
Approved
Date submitted
5/09/2023
Date registered
20/09/2023
Date last updated
20/09/2023
Date data sharing statement initially provided
20/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Early oral feeding following free flap reconstruction for oral cancer
Scientific title
Investigating patient outcomes, including complication rates and length of hospital stay, associated with early oral feeding after free flap reconstruction for cancer of the oral cavity
Secondary ID [1] 310541 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral cancer 331364 0
Condition category
Condition code
Cancer 328111 328111 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who undergo free flap reconstruction of the oral cavity will be eligible to participate. Typically, these patients remain nil by mouth and reliant on enteral nutrition for between 6-12 days, if not longer. Therefore, this study will explore the impact of early oral feeding (fluids +/- solids) on patient outcomes.
Those patients who consent to participate in the new research will commence on a new speech pathologist led early oral feeding protocol based on the one developed and trialed by a team in the United Kingdom (Brady et al. 2021). This protocol aims to introduce oral intake (fluids and/or solids) on Day 1 post-operatively, or as early as possible, as long as it is deemed safe to do so following a bedside clinical assessment by a speech pathologist. Should the participants be deemed not safe to swallow following a bedside assessment, the speech pathologist will re-assess the patient at regular time points and will commence oral feeding once they are safe to do so. Regular speech pathologist assessments will occur, as per standard and current clinical practice, to guide the progression of the oral diet. A face-to-face semi-structured interview exploring patient perspectives and experiences related to resuming oral intake after surgery will also be conducted by one of the researchers approximately 4-6 weeks after the surgery.
The intervention will take place across two locations in the Illawarra Shoalhaven Local Health District: The Wollongong Hospital and Wollongong Private Hospital.

A brief description of the protocol has been described below and will be conducted by the speech pathologist.
Day 1 post-operatively:
1. Oromotor assessment
2. In the event of a tracheostomy, the patient is seen for assessment of suitability for tracheostomy cuff deflation +/- speaking valve placement
3. Clinical evaluation of swallowing with sips of water +/- smooth puree diet
4. Close working with dietitian to inform non-oral feeding plan

Days 3-5 post-operatively:
1. Oromotor assessment
2. In the event of a tracheostomy, tracheostomy weaning/decannulation
3. Clinical evaluation of swallowing with sips of water +/- smooth puree diet +/- soft and moist diet +/- soft and bite sized diet
4. Close working with dietitian to inform non-oral feeding plan plus removal of NGT

Days 7-14 post-operatively:
1. Oromotor assessment
2. In the event of a tracheostomy, tracheostomy weaning/ decannulation
3. Clinical evaluation of swallowing with sips of water +/- smooth puree diet +/- soft and moist diet +/- soft and bite sized diet +/- regular easy chew diet
4. Close working with dietitian to inform non-oral feeding plan plus removal of NGT/conversion to gastrostomy.

Speech pathology assessments are expected to take approximately 20-30 minutes. They will be conducted on day 1, then every 48-72 days after to guide the progression of the diet.
All patients will still receive either a nasogastric tube (NGT) or percutaneous endoscopic gastrostomy (PEG) to assist meet nutritional needs as per current standard practice

The electronic medical notes will be used to monitor adherence to the protocol and identify barriers to administering the protocol.


Reference: Brady, G, Leigh-Doyle, L, Riva, F, Kerawala, C & Roe, J 2022 ‘Early post-operative feeding: An investigation of early functional outcomes for oral cancer patients treated with surgical resection and free flap reconstruction’, Dysphagia, vol. 37, no. 4, pp. 1008-1013
Intervention code [1] 326932 0
Rehabilitation
Comparator / control treatment
A historical control group will be used. Retrospective data from the local health area will be used as the historical control and compared with the prospective arm. This data will be gathered from electronic medical notes from January 2017 to December 2022
Potential bias will be minimised in the following ways: 1) patients will be matched (1:1) for important demographic data such as age, sex, disease stage; 2) data will be collected from the same institution as the prospective cohort and 3) recent historical controls will be used.
Control group
Historical

Outcomes
Primary outcome [1] 335985 0
Complication rates, including Clavien-Dindo classification, free flap failure rate, fistula formation, dehiscence
These will be collected from the electronic medical notes
Timepoint [1] 335985 0
Within 30 days of surgery
Primary outcome [2] 335986 0
Length of hospital stay
This will be collected from the electronic medical notes
Timepoint [2] 335986 0
Defined as date of discharge from hospital minus date of surgery
Secondary outcome [1] 426371 0
Speech and swallow outcomes including:
-The performance status scale for head and neck cancer (PSS-HN):
normalcy of diet (PSS-HN NOD)
eating in public (PSS-HN EIP)
understandability of speech (PSS-HN speech)

These will be assessed as a composite outcome
Timepoint [1] 426371 0
Conducted at:
Baseline (pre-surgery),
On discharge from hospital
4-6 weeks post surgery*
*Only the 4-6 week time point is additional for the research project, the other measures are collected as part of standard care
Secondary outcome [2] 426372 0
Nutritional status:
- Nutritional status (using Patient-Generated Subjective Global Assessment (PG SGA) or the Global Leadership Initiative on Malnutrition (GLIM) tools): collected from dietitian notes via electronic medical records
Timepoint [2] 426372 0
Baseline: pre-surgery
During admission: within 72 hours of surgery, and weekly after (if applicable)
On discharge from hospital.
Secondary outcome [3] 426373 0
Feasibility including:
-Number of patients recruited to the study- this will be assessed through an audit of study recruitment records.
-Retention rate of participants (number who completed primary outcome measure divided by the number of consented participants * 100). This will be assessed through an audit of study recruitment records.
-Change in speech pathology resources to deliver protocol. This will be assessed by comparing the number of occasions of service to administer the protocol (collected from study recruitment records) and compared to the average number of occasions of service collected from medical records of the historical controls
Timepoint [3] 426373 0
At completion of study
Secondary outcome [4] 426382 0
One-year survival
Timepoint [4] 426382 0
Retrieved from medical notes at one year post-surgery
Secondary outcome [5] 426383 0
Acceptability via semi-structured interviews
The semi-structured interviews will be conducted in person and will be audio-recorded and transcribed for the purpose of analyses. They are expected to take approximately 30 minutes
Timepoint [5] 426383 0
4-6 weeks after surgery
Secondary outcome [6] 426671 0
-Anthropometric details (height, weight, BMI, weight loss)
These details will be collected from the electronic medical records.
Timepoint [6] 426671 0
Baseline: pre-surgery
During admission: within 72 hours of surgery, then weekly after (if applicable)
On discharge from hospital
Secondary outcome [7] 426672 0
-Functional oral intake scale. Collected from electronic medical notes
Timepoint [7] 426672 0
Baseline: pre-surgery
On discharge from hospital
Secondary outcome [8] 426673 0
-Method and duration of non-oral feeding period
From electronic medical notes
Timepoint [8] 426673 0
Duration of non-oral feeding= day non-oral feeding ceased minus day non-oral feeding commenced
Secondary outcome [9] 426674 0
-Days till nasogastric tube is removed
Calculated from electronic medical notes
Timepoint [9] 426674 0
Calculation= day nasogastric tube removed minus day nasogastric tube inserted
Secondary outcome [10] 426675 0
-Barriers to oral intake reported: assessed via medical notes
Timepoint [10] 426675 0
During hospital admission: at each visit from the speech pathologist (i,e, on day one, then every couple of days as per speech pathology assessment)
Secondary outcome [11] 426676 0
- Diet texture prescribed on discharge
Assessed from speech pathology assessment via electronic medical records
Timepoint [11] 426676 0
On discharge from hospital
Secondary outcome [12] 426677 0
-Number of patients meeting estimated energy requirements: Assessed via food charts + electronic medical notes for patients.
Timepoint [12] 426677 0
During hospital admission: within 24 hours of commencing oral intake. Estimate energy requirements will be collected daily during hospital admission.
Secondary outcome [13] 426678 0
MD Anderson Dysphagia Inventory (MDADI)
This tool will be conducted by the speech pathologist.
Timepoint [13] 426678 0
Collected at:
-Baseline: Pre-surgery
-On discharge from hospital
-4-6 weeks post-surgery*Only the 4-6 week time point is additional for the research project, the other measures are collected as part of standard care
Secondary outcome [14] 426679 0
Evidence of dysphagia on clinical evaluation of swallowing
Timepoint [14] 426679 0
Collected at:
-Baseline: Pre-surgery
-On discharge from hospital
-4-6 weeks post-surgery*Only the 4-6 week time point is additional for the research project, the other measures are collected as part of standard care
Secondary outcome [15] 426680 0
Speech Handicap Index (SHI):
This tool will be conducted by the speech pathologist
Timepoint [15] 426680 0
Collected at
-Baseline: Pre-surgery
-On discharge from hospital
-4-6 weeks post-surgery*Only the 4-6 week time point is additional for the research project, the other measures are collected as part of standard care

Eligibility
Key inclusion criteria
All patients with oral cancer undergoing oral mucosal resection with free flap reconstruction (including composite reconstruction/ salvage resection following previous radiotherapy or surgical management for osteoradionecrosis)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Children (<18 years)
-Those unable to provide informed consent
-Severely dysphagic patients that are 100% nil by mouth and 100% tube dependent due to an unsafe swallow.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data analysis will be conducted using Jamovi software (The Jamovi project 2021). After consultation with the biostatistician at Research Central, The Wollongong Hospital, a power calculation was conducted using the estimated effect size calculated in a similar, large prospective study by Kerawala et al. The estimated effect size of early oral feeding on the length of hospital stay in this study was found to be d=0.7. Based on this effect size, it is estimated that 38 participants in each cohort will be required for statistical significance (p<0.05, 80% power).
Descriptive statistics will be used to describe the demographic information of those participating in the study (means and standard deviations for continuous variables and number and percentage for categorical variables). Student t tests or Mann Whitney U tests will be used to determine statistical significance between groups for continuous normally distributed and skewed data, respectively. Chi-squared test or Fisher’s exact test will be used to determine statistical significance between groups for categorical data.

Qualitative data:
Individual interviews will be digitally recorded and transcribed verbatim using Otter.ai software. The PhD Student (who also conducted the interviews), will then go through the transcriptions and remove any identifiable data. Braun and Clarke’s guide to thematic analysis will be used for qualitative analysis and conducted in the following way. Firstly, the PhD student will immerse herself in the data to become familiar with the content of the transcripts and develop an understanding of what was being said. Following immersion, inductive coding will be performed in line by line and iterative process using NVivo 12 Plus qualitative software (QSR International Pty Ltd), with key words, phrases or paragraphs being assigned a code. Once the transcripts have been coded, categories will be formed from codes about similar concepts. Finally, the categories identified will be used to develop themes arising from the interviews. To increase the rigour of results, a secondary researcher, the supervisor of the PhD student, will independently review at least 10% of the interview transcripts, conferring with the primary researcher on the coding process and themes, before a final list of themes and subthemes with exemplar quotes are established following consensus between researchers. This approach has been selected for its ability to generate thorough and sophisticated meaning from interviews.

Reference:
Braun, V &Clarke, V 2006. ‘Using thematic analysis in psychology’, Qualitative research in psychology, vol. 3, no. 2, pp.77-101

Kerawala, CJ, Riva, F & Paleri, V., 2021, ‘The impact of early oral feeding following head and neck free flap reconstruction on complications and length of stay’, Oral Oncology, vol. 113, p. 105094

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
6/10/2025
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25494 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 25495 0
Wollongong Private Hospital - Wollongong
Recruitment postcode(s) [1] 41306 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 314795 0
Government body
Name [1] 314795 0
Illawarra Shoalhaven Local Health District
Country [1] 314795 0
Australia
Primary sponsor type
Government body
Name
Illawarra Shoalhaven Local Health District
Address
The Wollongong HospitalLoftus Street, Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 316723 0
None
Name [1] 316723 0
Address [1] 316723 0
Country [1] 316723 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313753 0
Joint University of Wollongong Health and Medical Human Research Ethics Committee
Ethics committee address [1] 313753 0
Ethics committee country [1] 313753 0
Australia
Date submitted for ethics approval [1] 313753 0
23/05/2023
Approval date [1] 313753 0
19/07/2023
Ethics approval number [1] 313753 0
2020/ETH01105

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

Contacts
Principal investigator
Name 129246 0
Ms Olivia Fischer
Address 129246 0
The Wollongong Hospital, Illawarra Shoalhaven Local Health District, Loftus Street Wollongong NSW 2500
Country 129246 0
Australia
Phone 129246 0
+61 403878715
Fax 129246 0
Email 129246 0
[email protected]
Contact person for public queries
Name 129247 0
Olivia Fischer
Address 129247 0
The Wollongong Hospital, Illawarra Shoalhaven Local Health District, Loftus Street Wollongong NSW 2500
Country 129247 0
Australia
Phone 129247 0
+61 403878715
Fax 129247 0
Email 129247 0
[email protected]
Contact person for scientific queries
Name 129248 0
Jessica Boehm
Address 129248 0
The Wollongong Hospital, Illawarra Shoalhaven Local Health District, Loftus Street Wollongong NSW 2500
Country 129248 0
Australia
Phone 129248 0
+61 436661265
Fax 129248 0
Email 129248 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


What supporting documents are/will be available?

No Supporting Document Provided



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.