Lenalidomide for Lean Body Mass and Muscle Strength in Inflammatory Cancer Cachexia Syndrome
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Cantonal Hospital of St. Gallen Florian Strasser, MD ABHPM