Cancer Cachexia Syndrome Clinical Trial
Official title:
Effect of Lenalidomide (Revlimid®) in Solid Tumour Patients With Inflammatory Cancer Cachexia Syndrome on Lean Body Mass and Muscle Strength: A Multicenter, Proof-of-concept Study of Fixed Dose or CRP-response-guided Dose of Lenalidomide in Relation to New Standard Basic Cachexia Management (Receiving Placebo).
Cancer cachexia syndrome (CCS) is frequent, causing high morbidity and mortality in affected
ones. The mechanism is catabolism caused by the tumour. CRP is a surrogate marker for
catabolism. There are no effective treatment options against CCS. Lenalidomide, a derivate of
thalidomide, is an immunomodulatory drug (IMiD®). One of its' main effect is a decrease in
inflammatory cytokines. As CCS treatment, thalidomide has shown in a randomized controlled
trial to stabilize lean body mass. The effect of lenalidomide in solid tumour patients was
negligible although, there might be a decrease in tumour progression. However, even if
lenalidomide may be uninteresting as an anticancer treatment it might affect CCS dynamics.
Respective data are currently lacking. Therefore, a dose level where an anticancer effect
could be expected was chosen (group A). Relevant anti-inflammatory effect may occur below the
commonly used doses to achieve tumour control, which is expected to be the main anti-cachexia
effect. Therefore, a second CRP-response guided treatment arm (group B) was chosen.
Hypothesis: To test whether the response rate under new standard basic cachexia management
will be at the estimated 5% and with lenalidomide (either fixed dose or CRP-guided dose) in
addition to basic cachexia management at least 25%.
The primary objective of this study is to assess the efficacy of lenalidomide on lean body
mass and handgrip strength in advanced solid tumour patients with inflammatory CCS.
n/a