Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000391875
Ethics application status
Approved
Date submitted
7/01/2021
Date registered
8/04/2021
Date last updated
10/03/2022
Date data sharing statement initially provided
8/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating taste changes in patients with head and neck cancer and their association with genes and dietary behaviour
Scientific title
A feasibility study to investigate taste changes and their association with genes and dietary behaviour in patients with head and neck cancer
Secondary ID [1] 303111 0
NONE
Universal Trial Number (UTN)
U1111-1263-5345
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and neck cancer 320207 0
Taste perception 320209 0
Dietary Intake 320210 0
Nutritional Status 320211 0
Condition category
Condition code
Cancer 318147 318147 0 0
Head and neck
Diet and Nutrition 318148 318148 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
- Participants will be asked to attend 4 appointments (either in person or via telehealth) to complete clinical assessments and questionnaires as described below at baseline, and then at 1, 3, and 6 months post treatment

- Participants will be asked to complete the following questionnaires and/or clinical assessments:
1. Weight & height will be measured using scales and stadiometer and nutritional status will be assessed using the Patient Generated Subjective Global Assessment tool
2. Taste and smell perception will be assessed using the Monell Flavor Quiz
3. An individual’s inborn “taster status” is primarily determined by genetic variation within the bitter taste receptor gene TAS2R38, which determines the ability to perceive a specific bitter substance phenylthiocarbamide (PTC). Therefore patients’ taster status will be determined by their taste scores of PTC in the Monell Flavor Quiz.
4. Dietary intake will be assessed using the online Automated Self Administered 24-hour recall (ASA24-2016)
5. Side effects will be assessed using the CTCAE v5 tool
6. Acceptability of assessment tools will be assessed using a brief questionnaire (Likert scale)

- Each observation session (at baseline and 1 ,3, 6 months post treatment) is anticipated to take a total of 45minutes to complete with the researcher and an additional 30minutes completing the online dietary questionnaire.

- Participants will attend a face-to-face study visit for their baseline assessment but at all other time points the observation will be conducted via videoconference. The dietary assessment is completed by the participant online at home.

- The primary research investigator will be responsible for conducting the observation sessions and assessments.
Intervention code [1] 319414 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326134 0
Study Feasibility (Composite outcome):
1. Recruitment rates - This will be assessed following an audit of the study database to determine the number of participants consented to the trial compared to the number of participants screened for eligibility for the trial (%)
2. Consent rates - This will be assessed following an audit of the study database to determine the number of participants consented to the trial compared to the number of participants determined eligible for the trial (%)
3. Attrition rates - This will be assessed following an audit of the study database to determine the number of enrolled participants that completed the trial (%)
4. Reasons for consent failure and attrition - This will be assessed following audit of study database.
Timepoint [1] 326134 0
On completion of study
Primary outcome [2] 326135 0
Study Fidelity (Composite outcome):
1. Ability for participants to complete online self administered dietary recall (ASA24) - This will be assessed following an audit of the study database to determine proportion of assessments completed at each timepoint
2. Ability for participants to complete the taste testing procedures (Monell Flavor Quiz) - This will be assessed following an audit of the study database to determine proportion of assessments completed at each timepoint
3. Ability for participants to complete the nutrition assessments (weight and patient generated subjective global assessment tool) - This will be assessed following an audit of the study database to determine proportion of assessments completed at each timepoint
4. Reasons for non-fidelity to study procedures and assessments - This will be assessed following an audit of the study database
Timepoint [2] 326135 0
Baseline & 1,3,6 months post treatment completion
Primary outcome [3] 326136 0
Study acceptability
- Acceptability of study assessment tools used by participants - assessed using the Likert scale questionnaire at each timepoint
Timepoint [3] 326136 0
Baseline & 1,3,6 months post treatment completion
Secondary outcome [1] 390218 0
Taste perception - assessed using the Monell Flavor Quiz
Timepoint [1] 390218 0
Baseline & 1,3,6 months post treatment completion
Secondary outcome [2] 390220 0
Weight - assessed using digital scales
Timepoint [2] 390220 0
Baseline & 1,3,6, months post treatment completion
Secondary outcome [3] 390221 0
Nutritional Status - assessed using Patient Generated Subjective Global Assessment (PGSGA) tool
Timepoint [3] 390221 0
Baseline & 1,3,6, months post treatment completion
Secondary outcome [4] 390222 0
Dietary Intake - assessed using the Automated Self Assessment 24-hour recall (ASA24-2016 Australia) as a composite outcome to include:
1. Energy intake (kcal/d)
2. Macronutrient intake - including Protein, Carbohydrate and Fat (g/d)
Timepoint [4] 390222 0
Baseline & 1,3,6 months post treatment completion
Secondary outcome [5] 390223 0
Treatment Outcomes (composite outcome) - assessed using medical chart review to include:
1. % of prescribed chemotherapy received
2. % of prescribed radiotherapy received
Timepoint [5] 390223 0
1 month post treatment completion
Secondary outcome [6] 390224 0
Toxicity Outcomes (composite outcome) - assessed using clinical assessment tool (CTCAE v5) to include:
1. Dysgeusia
2. Dry mouth
3. Mucositis oral
4. Salivary duct inflammation
Timepoint [6] 390224 0
Baseline & 1,3,6 months post treatment completion
Secondary outcome [7] 392706 0
Smell perception - assessed using the Monell Flavor Quiz
Timepoint [7] 392706 0
Baseline & 1,3,6 months post treatment completion

Eligibility
Key inclusion criteria
All patients aged > 18 years undergoing curative intent definitive radiotherapy or chemoradiotherapy (unilateral or bilateral) for oral cavity, oropharyngeal or hypopharyngeal HNSCC at RBWH who can provide written informed consent. Participants will also need to have appropriate technology (e.g. computer/tablet/smart phone with internet connection) to support telehealth sessions and completion of the online dietary assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <18, unable to communicate in English, inability to provide written informed consent, sensory (taste) dysfunction of other medical causes (including history of traumatic brain injury, history of neurological disorders, history of middle ear surgery/infection) and current smoker.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As this is a pilot feasibility study no formal sample size calculation will be completed. Patients that consent to participate within the six months recruitment period will be included. With over 600 patients attending this clinic per year, there are usually at least four patients per week who are expected to meet the inclusion criteria. Based on a conservative 50% consent rate from these eligible patients, we would expect to recruit approximately 2 patients/week and therefore achieve a practicable target of approximately 50 patients over a 6-month period. This will be adequate to assess feasibility of the proposed study.

Descriptive statistics and narrative reporting will be used to describe feasibility outcomes. Analyses will be done separately for each taste modality (sweet, bitter, sour, salty) for the comparison of the changes in taste perception over time and for the recovery time between modalities. To investigate the effect of pre-treatment taste and taster status on post-treatment changes in taste, descriptive and bivariate analyses will be performed on pre-treatment taste scores with changes in taste perception, dietary intake and recovery time. Any large effects of taster status may suggest a genetic influence on post-treatment changes in taste perception. Statistical modelling such as mixed effects models for changes in taste perception and survival analysis for recovery time may be considered depending on final sample size achieved during the recruitment period. Covariates of age, sex and other clinical values of interest (e.g. enteral nutrition intake, radiation dosage to parotids, addition of concurrent chemotherapy, P16 status etc.) will be considered for all analyses to adjust for any confounding effects.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
8/04/2021
Date of last participant enrolment
Anticipated
10/09/2021
Actual
28/01/2022
Date of last data collection
Anticipated
29/07/2022
Actual
Sample size
Target
50
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18340 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 32418 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 307520 0
Hospital
Name [1] 307520 0
Royal Brisbane Women's Hospital Foundation
Country [1] 307520 0
Australia
Primary sponsor type
Individual
Name
Teresa Brown
Address
Nutrition & Dietetics
Royal Brisbane Women's Hospital
Butterfield Street
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 308198 0
None
Name [1] 308198 0
Address [1] 308198 0
Country [1] 308198 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307587 0
Royal Brisbane Women's Hospital HREC
Ethics committee address [1] 307587 0
Ethics committee country [1] 307587 0
Australia
Date submitted for ethics approval [1] 307587 0
20/11/2020
Approval date [1] 307587 0
15/12/2020
Ethics approval number [1] 307587 0
HREC/2020/QRBW/66388

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

Contacts
Principal investigator
Name 107770 0
Dr Teresa Brown
Address 107770 0
Department of Nutrition & Dietetics
Level 2 James Mayne Building
Royal Brisbane & Women's Hospital
Butterfield Street
Herston
QLD 4029
Country 107770 0
Australia
Phone 107770 0
+61 7 3646 6043
Fax 107770 0
Email 107770 0
[email protected]
Contact person for public queries
Name 107771 0
Teresa Brown
Address 107771 0
Department of Nutrition & Dietetics
Level 2 James Mayne Building
Royal Brisbane & Women's Hospital
Butterfield Street
Herston
QLD 4029
Country 107771 0
Australia
Phone 107771 0
+61 7 3646 6043
Fax 107771 0
Email 107771 0
[email protected]
Contact person for scientific queries
Name 107772 0
Teresa Brown
Address 107772 0
Department of Nutrition & Dietetics
Level 2 James Mayne Building
Royal Brisbane & Women's Hospital
Butterfield Street
Herston
QLD 4029
Country 107772 0
Australia
Phone 107772 0
+61 7 3646 6043
Fax 107772 0
Email 107772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial after de-identification and publication of main findings
When will data be available (start and end dates)?
Following main results publication and for period that data is required to be stored for according to ethical standards (i.e. 15 years).
Available to whom?
The direct research team and on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
To assist informing larger trial designs and future meta-analyses studies
How or where can data be obtained?
Access subject to approvals by Principal Investigator - [email protected]


What supporting documents are/will be available?




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.