Clinical Trial: Lenalidomide for Lean Body Mass and Muscle Strength in Inflammatory Cancer Cachexia Syndrome

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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-

Brief 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.


Detailed Summary:
Sponsor: Cantonal Hospital of St. Gallen

Current Primary Outcome:

  • Lean Body Mass [ Time Frame: after 8 weeks treatment ]
  • and Handgrip Strength [ Time Frame: after 8 weeks treatment ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • SAEs [ Time Frame: for 12 weeks ]
  • nutritional intake [ Time Frame: after 8 weeks of treatment ]
  • physical functioning [ Time Frame: after 8 weeks of treatment ]
  • inflammation [ Time Frame: for 8 weeks ]
  • eating related symptoms (FAACT) [ Time Frame: after 8 weeks of treatment ]
  • tumour dynamics (CT) [ Time Frame: after 8 weeks of treatment ]


Original Secondary Outcome: Same as current

Information By: Cantonal Hospital of St. Gallen

Dates:
Date Received: May 12, 2010
Date Started: May 2010
Date Completion: December 2012
Last Updated: May 19, 2010
Last Verified: February 2010