Klinische Forschung

Multizentrisch, KSSG als Hauptzentrum

Zentrum für Integrative Medizin, Medizinische Onkologie und Hämatologie, Neurologie

Abgebrochen

2009

2012

Industrie

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. Condition Intervention Phase Cancer Cachexia Syndrome Drug: Lenalidomide Other: basic cachexia management (prokinetics, physical activity counselling, nutritional counselling) Phase I Phase II Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment Arms Assigned Interventions fix dose lenalidomide 25mg, basic cachexia management: Experimental dose reduction according to toxicity possible Intervention: Drug: Lenalidomide Drug: Lenalidomide 25mg od, dose reduction according to toxicity Other Name: Revlimid CRP-response guided lenalidomide, basic cachexia management: Experimental start with 5mg od and increase of dosage to 10mg, 15mg or 25mg until CRP response (50% decrease) Intervention: Drug: Lenalidomide Drug: Lenalidomide start with 5mg od and increase of dosage to 10mg, 15mg or 25mg until CRP response (50% decrease) Other Name: Revlimid placebo: Experimental to generate data about basic cachexia management, no direct comparator for treatment arms efficacy Intervention: Other: basic cachexia management (prokinetics, physical activity counselling, nutritional counselling) Other: basic cachexia management (prokinetics, physical activity counselling, nutritional counselling) twice during study

Revlimid, cancer cachexie,

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Primary Outcome Measures: •Lean Body Mass [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ] •and Handgrip Strength [ Time Frame: after 8 weeks treatment ] [ Designated as safety issue: No ] Secondary Outcome Measures: •SAEs [ Time Frame: for 12 weeks ] [ Designated as safety issue: Yes ] •nutritional intake [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ] •physical functioning [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ] •inflammation [ Time Frame: for 8 weeks ] [ Designated as safety issue: No ] •eating related symptoms (FAACT) [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ] •tumour dynamics (CT) [ Time Frame: after 8 weeks of treatment ] [ Designated as safety issue: No ]