No registrations found.
ID
Source
Brief title
Health condition
Toxicity, chemotherapy, body composition, head and neck cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Relationship between cisplatin pharmacokinetics, skeletal muscle mass and body surface area
Secondary outcome
- Chemotherapy related toxicity and dose-limiting toxicity
- Quality of life
- Hospital expenditures
Background summary
Treatment of advanced stage head and neck squamous cell carcinoma (HNSCC) by chemoradiotherapy (CRT) with platinum-based chemotherapy is associated with frequent severe toxicity, requiring treatment de-escalation or termination of chemotherapy in at least 30% of patients. In recent years a relationship between low skeletal muscle mass, as measured using routine diagnostic CT scans, and chemotherapy related toxicity has been suggested in a variety of tumour types including HNSCC. A potential explanation for this relationship is that platinum compounds such as cisplatin are hydrophilic and only distribute into the fat-free body mass. Skeletal muscle mass is the largest contributor to fat-free mass. Chemotherapy dose is currently calculated using a patient’s body surface area (BSA), which does not take into account abnormal body composition. The hypothesis of this study is that cisplatin pharmakinetic parameters have a stronger association with skeletal muscle mass than with BSA. It is possible that the current chemotherapy dosing method using BSA insufficiently takes into account individual differences in body composition, and that cisplatin is relatively overdosed in patients with low skeletal muscle mass. This study will investigate the association between cisplatin pharmacokinetics and skeletal muscle mass, and the correlation between cisplatin pharmacokinetics and BSA. Secondary, this study will investigate the association between cisplatin pharmacokinetics and chemotherapy related toxicity including dose-limiting toxicity and quality of life.
Study objective
In recent years a relationship between low skeletal muscle mass, as measured using routine diagnostic CT scans, and chemotherapy related toxicity has been suggested in a variety of tumour types including head and neck squamous cell carcinoma (HNSCC). A potential explanation for this relationship is that platinum compounds such as cisplatin are hydrophilic and only distribute into the fat-free body mass. Skeletal muscle mass is the largest contributor to fat-free mass. Chemotherapy dose is currently calculated using a patient’s body surface area (BSA), which does not take into account abnormal body composition. The hypothesis of this study is that cisplatin pharmakinetic parameters have a stronger association with skeletal muscle mass than with BSA. It is possible that the current chemotherapy dosing method using BSA insufficiently takes into account individual differences in body composition, and that cisplatin is relatively overdosed in patients with low skeletal muscle mass.
Study design
- Baseline measurements of skeletal muscle mass, quality of life and other study related parameters before start of chemoradiotherapy
- One quality of life measurement during chemoradiotherapy
- One quality of life measurement after the end of chemoradiotherapy
Intervention
none
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7469 |
| NTR-old | NTR7711 |
| Other | KWF subsidie: project number 11444 : METC UMC Utrecht protocolnummer 18-225/D |