ANZCTR - Registration

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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]

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

Taste perception

Dietary Intake

Nutritional Status

Condition category

Condition code

Cancer

Head and neck

Diet and Nutrition

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]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

On completion of study

Primary outcome [2]

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]

Baseline & 1,3,6 months post treatment completion

Primary outcome [3]

Study acceptability
- Acceptability of study assessment tools used by participants - assessed using the Likert scale questionnaire at each timepoint

Timepoint [3]

Baseline & 1,3,6 months post treatment completion

Secondary outcome [1]

Taste perception - assessed using the Monell Flavor Quiz

Timepoint [1]

Baseline & 1,3,6 months post treatment completion

Secondary outcome [2]

Weight - assessed using digital scales

Timepoint [2]

Baseline & 1,3,6, months post treatment completion

Secondary outcome [3]

Nutritional Status - assessed using Patient Generated Subjective Global Assessment (PGSGA) tool

Timepoint [3]

Baseline & 1,3,6, months post treatment completion

Secondary outcome [4]

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]

Baseline & 1,3,6 months post treatment completion

Secondary outcome [5]

Treatment Outcomes (composite outcome) - assessed using medical chart review to include:
1. % of prescribed chemotherapy received
2. % of prescribed radiotherapy received

Timepoint [5]

1 month post treatment completion

Secondary outcome [6]

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]

Baseline & 1,3,6 months post treatment completion

Secondary outcome [7]

Smell perception - assessed using the Monell Flavor Quiz

Timepoint [7]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Herston

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Brisbane Women's Hospital Foundation

Address [1]

Royal Brisbane Women's Hospital Foundation
Royal Brisbane Women's Hospital
Butterfield Street
Herston
QLD 4029

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane Women's Hospital HREC

Ethics committee address [1]

Lower Ground Floor, James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
QLD
4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/11/2020

Approval date [1]

15/12/2020

Ethics approval number [1]

HREC/2020/QRBW/66388

Summary

Brief summary

Project Aims - This project aims to assess the feasibility of conducting a study to determine a patient’s individual taste status prior to receiving cancer treatment, and how these radiotherapy and chemotherapy treatments impact on their taste and dietary behaviour after treatment completion.

Who is it for? - You may be eligible for this study if you are aged 18 years or older and you are undergoing radiotherapy or chemoradiotherapy treatment for head and neck squamous cell cancer.

Study Details - Participants who enrol in this study will be asked to complete a series of questionnaires about their diet and taste perceptions prior to starting treatment, and again at 1 month, 3 months and 6 months after treatment completion. It is anticipated that participants will be able to complete these questionnaires & assessments via a telehealth appointment of approximately 45 minutes, and an additional 30 minutes completing an online survey, at each of the timepoints described.

Study Outcomes - It is hoped this research will provide valuable data on the effect cancer treatments may have on the taste and smell perceptions of patients with head and neck cancer and how this impacts on their ability to eat. This data will also be used to inform a larger study to identify possible genetic markers for these individual variations.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Teresa Brown

Address

Department of Nutrition & Dietetics
Level 2 James Mayne Building
Royal Brisbane & Women's Hospital
Butterfield Street
Herston
QLD 4029

Country

Australia

Phone

+61 7 3646 6043

Fax

teresa.brown@health.qld.gov.au

Contact person for public queries

Name

Teresa Brown

Address

Department of Nutrition & Dietetics
Level 2 James Mayne Building
Royal Brisbane & Women's Hospital
Butterfield Street
Herston
QLD 4029

Country

Australia

Phone

+61 7 3646 6043

Fax

teresa.brown@health.qld.gov.au

Contact person for scientific queries

Name

Teresa Brown

Address

Department of Nutrition & Dietetics
Level 2 James Mayne Building
Royal Brisbane & Women's Hospital
Butterfield Street
Herston
QLD 4029

Country

Australia

Phone

+61 7 3646 6043

Fax

teresa.brown@health.qld.gov.au

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 - Teresa.brown@health.qld.gov.au

What supporting documents are/will be available?

Doc. No.	Type	Email	Attachment
10181	Study protocol	teresa.brown@health.qld.gov.au	381178-(Uploaded-07-01-2021-11-42-52)-Study-related document.pdf
10182	Informed consent form	teresa.brown@health.qld.gov.au	381178-(Uploaded-07-01-2021-11-43-38)-Study-related document.pdf
10183	Ethical approval	teresa.brown@health.qld.gov.au	381178-(Uploaded-07-01-2021-11-44-00)-Study-related document.pdf

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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