Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000521628
Ethics application status
Approved
Date submitted
1/05/2023
Date registered
19/05/2023
Date last updated
19/05/2023
Date data sharing statement initially provided
19/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The ASPIRE Trial - understanding the impact of mucositis on cachexia in head and neck cancer
Scientific title
GDF-15 levels and clinical/biological correlates in head and neck cancer patients with mucositis: developing a risk model for cachexia
Secondary ID [1] 309564 0
Nil
Universal Trial Number (UTN)
Trial acronym
ASPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
head and neck cancer 329855 0
mucositis 329856 0
cachexia 329857 0
Condition category
Condition code
Cancer 326764 326764 0 0
Head and neck
Inflammatory and Immune System 326833 326833 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 326834 326834 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 326835 326835 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The exposure of interest is people undergoing radiotherapy treatment for head and neck cancer. Participants will be monitored over the 7 weeks of their radiotherapy treatment, and at routine follow up at 3 months. If feasible, participants will also be asked to undergo an additional assessment at 12 and 24 months after completion of radiotherapy.
Participants will be asked to provide:
- Up to 6 blood samples (aligned with routine blood tests)
- Up to 6 saliva samples
- 5 questionnaires/surveys
Intervention code [1] 325983 0
Not applicable
Comparator / control treatment
No comparator - observational study only
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334612 0
Oral mucositis using the Mucositis Weekly Questionnaire
Timepoint [1] 334612 0
End of radiotherapy
Primary outcome [2] 334616 0
GDF-15 concentrations in blood
Timepoint [2] 334616 0
End of radiotherapy
Secondary outcome [1] 421408 0
Body weight using digital scales at clinic appointment
Timepoint [1] 421408 0
3 months after radiotherapy completion
Secondary outcome [2] 421409 0
Body mass index assessed at clinic appointment using digital scales and stadiometer
Timepoint [2] 421409 0
3 months after radiotherapy completion
Secondary outcome [3] 421410 0
Mucositis burden determined using the Mucositis Weekly Questionnaire
Timepoint [3] 421410 0
End of radiotherapy treatment
Secondary outcome [4] 421411 0
Cachexia (determined by The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire QLQ-CAX24 questionnaire)
Timepoint [4] 421411 0
3 months after radiotherapy completion
Secondary outcome [5] 421412 0
Hand grip strength using a digital hand dynamometer
Timepoint [5] 421412 0
3 months after radiotherapy completion
Secondary outcome [6] 421413 0
Upper arm circumference determined using a measuring tape
Timepoint [6] 421413 0
3 months after radiotherapy completion
Secondary outcome [7] 421414 0
Quality of life (determined using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire QLQ-C30)
Timepoint [7] 421414 0
3 months after radiotherapy completion
Secondary outcome [8] 421417 0
Quality of life determined using European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire HN24)
Timepoint [8] 421417 0
3 months after radiotherapy completion
Secondary outcome [9] 421418 0
Symptom burden determined using Edmonton Symptom Assessment Scale revised to include sleep and constipation (ESAS-R-SC)
Timepoint [9] 421418 0
3 months after radiotherapy completion
Secondary outcome [10] 421419 0
Tumor response (determined using RECIST)
Timepoint [10] 421419 0
3 months after radiotherapy completion
Secondary outcome [11] 421420 0
Progression free survival
Timepoint [11] 421420 0
12 months after radiotherapy completion

Eligibility
Key inclusion criteria
>18 years of age
Stage III and IV oropharyngeal and hypopharyngeal/laryngeal carcinoma treated with definitive chemoradiation
Scheduled to receive definitive intensity modulated radiotherapy + cisplatin-based chemotherapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients treated with systemic therapy other than cisplatin

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
All data will be evaluated in collaboration with the Australian Institute for Machine Learning to identify the most significant predictors (both individual and combined) of: i) GDF-15 concentrations, ii) cachexia, iii) tumor response, iv) relapse, and other study outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24628 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 40239 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 313753 0
Commercial sector/Industry
Name [1] 313753 0
Pfizer
Country [1] 313753 0
United States of America
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace
Adelaide
South Australia
Australia 5000
Country
Australia
Secondary sponsor category [1] 315573 0
None
Name [1] 315573 0
Address [1] 315573 0
Country [1] 315573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312924 0
CALHN HREC
Ethics committee address [1] 312924 0
Royal Adelaide Hospital
Adelaide
Australia 5000
Ethics committee country [1] 312924 0
Australia
Date submitted for ethics approval [1] 312924 0
Approval date [1] 312924 0
19/12/2022
Ethics approval number [1] 312924 0

Summary
Brief summary
The main purpose of this study is to better understand how changes in treatment impact muscle wasting (also known as cachexia) in people with head and neck cancer (HNC). In particular, we are interested in understanding the blood marker GDF-15 and swelling/ulceration of the mouth or gut (known as mucositis), and the relationship with cachexia.

This study is focused on people diagnosed with head and neck cancer, scheduled to undergo radiotherapy +/- chemotherapy.

The study will involve the collection of blood and saliva throughout 7 weeks of radiotherapy, with some additional questionnaires completed by the participant. All assessments will be performed at routine clinic visits to decrease the burden of participating.

By understanding the interaction between mucositis and cachexia, we hope to be able to identify people at risk of cachexia and direct them to appropriate care pathways early.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126354 0
Dr Hannah Wardill
Address 126354 0
Level 5S - Precision Cancer Medicine Theme (SORG)
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide
South Australia 5000
Australia
Country 126354 0
Australia
Phone 126354 0
+61 476870643
Fax 126354 0
Email 126354 0
[email protected]
Contact person for public queries
Name 126355 0
Hannah Wardill
Address 126355 0
Level 5S - Precision Cancer Medicine Theme (SORG)
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide
South Australia 5000
Australia
Country 126355 0
Australia
Phone 126355 0
+61 476870643
Fax 126355 0
Email 126355 0
[email protected]
Contact person for scientific queries
Name 126356 0
Hannah Wardill
Address 126356 0
Level 5S - Precision Cancer Medicine Theme (SORG)
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide
South Australia 5000
Australia
Country 126356 0
Australia
Phone 126356 0
+61 476870643
Fax 126356 0
Email 126356 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?
All study data (de-identified) will be shared on a clinical trial platform at completion of the trial. The specific platform will be based on the target journal and their preferences.
When will data be available (start and end dates)?
At completion of the trial after the primary data has been published. All data will be available for 7 years.
Available to whom?
Anyone with access to the site.
Available for what types of analyses?
All analyses will be permitted.
How or where can data be obtained?
A suitable data sharing platform will be selected at completion of the trial in alignment with the preferences of the journal in which we publish the results.


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.