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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48724

Enrollment

Registered

2018-06-21

Start date

2018-07-24

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

head and neck cancer laryngeal cancer throat cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Diagnosed with head and neck suamous cell carcinoma (histologically or cytology proven). * Scheduled for primary chemoradiotherapy with cisplatin or postoperative chemoradiotherapy with cisplatin * Over 18 years of age. * 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 patient receives treatment.

Design outcomes

Primary

Measure	Time frame
- To determine the association between cisplatin pharmacokinetic properties and BSA. - To determine the association between cisplatin pharmacokinetic properties and skeletal muscle mass.	—

Secondary

Measure	Time frame
- To investigate the association between cisplatin pharmacokinetic properties and the occurrence of chemotherapy related toxicity and treatment de-escalation or termination (dose-limiting toxicity). - To investigate the quality of life of patients undergoing CRT and its relationship with cisplatin pharmacokinetic properties and cisplatin related toxicity. (exploratory objective) - To investigate the healthcare related costs of patients undergoing CRT and its relationship with low skeletal muscle mass. (exploratory objective) - To investigate the association between several genetic variants and toxicity, in collaboration with the PGx study (protocol ID PGxLungCA01; NL53736.100.15).	—

Measure

Time frame

- To investigate the association between cisplatin pharmacokinetic properties and the occurrence of chemotherapy related toxicity and treatment de-escalation or termination (dose-limiting toxicity). - To investigate the quality of life of patients undergoing CRT and its relationship with cisplatin pharmacokinetic properties and cisplatin related toxicity. (exploratory objective) - To investigate the healthcare related costs of patients undergoing CRT and its relationship with low skeletal muscle mass. (exploratory objective) - To investigate the association between several genetic variants and toxicity, in collaboration with the PGx study (protocol ID PGxLungCA01; NL53736.100.15).

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Countries

Netherlands

Outcome results