Cisplatin pharmacokinetics and skeletal muscle mass in patients with head and neck cancer: is cisplatin overdosed in patients with low skeletal muscle mass?

CisPLATIn pharmacokinetics and Skeletal muscle MAss in patients with head and neck cancer: a proof-of-principle, prospective observational study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23217

Enrollment

Registered

2019-01-08

Start date

2018-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Toxicity, chemotherapy, body composition, head and neck cancer

Interventions

none

Eligibility

Inclusion criteria

Inclusion criteria: • Diagnosed with HNSCC (histologically or cytology proven). • Scheduled for CRT with conventional high-dose cisplatin with curative intent. • Eighteen years of age or older, and able to exercise their free will. • Sufficient understanding of the Dutch language to give informed consent.

Exclusion criteria

Exclusion criteria: • Major CT artefacts, impeding accurate muscle tissue identification on CT imaging. • Synchronous tumour(s) outside of the head and neck region, e.g. concurrent non-small cell lung cancer, for which the patienty receives concurrent treatment

Design outcomes

Primary

Measure	Time frame
Relationship between cisplatin pharmacokinetics, skeletal muscle mass and body surface area	—

Secondary

Measure	Time frame
- Chemotherapy related toxicity and dose-limiting toxicity - Quality of life - Hospital expenditures	—

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)