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The ASPIRE Trial - understanding the impact of mucositis on cachexia in head and neck cancer

GDF-15 levels and clinical/biological correlates in head and neck cancer patients with mucositis: developing a risk model for cachexia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000521628
Acronym
ASPIRE
Enrollment
23
Registered
2023-05-19
Start date
2023-07-05
Completion date
2025-07-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Sponsors

University of Adelaide
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

Patients treated with systemic therapy other than cisplatin

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026