A Phase II Double Blind Randomized Trial Comparing Standard Dosing Based on Body Surface Area Versus Dosing Based on Personalized Lean Body Mass in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Receiving First Line Cisplatin Based Chemotherapy
Cancer patients are highly variable in their body composition, specifically in the
proportion of fat and muscle. Some patients tend to gain fat and lose muscle (or lean body
mass) at the same time. These patients can develop severe muscle wasting, termed sarcopenia.
Patients with sarcopenia have more severe treatment related toxicity requiring delays, dose
reductions and stopping of treatment, and have reduced survival. One potential explanation
for this is that patients with sarcopenia have a reduced volume of lean body mass into which
chemotherapy drugs are distributed, resulting in a higher concentration and greater
toxicity. This study will randomize lung cancer patients to either the standard dosing
strategy based on body surface area or experimental, personalized dosing based on lean body
mass. Based on retrospective findings in this patient population, the investigators expect
to find that severe toxicity will be reduced for sarcopenic patients on the personalized
dosing arm based on lean body mass.
View this trial on ClinicalTrials.gov
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