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

NCT01127386 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-08-01

No results posted yet for this study

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.

Conditions

  • Cancer Cachexia Syndrome

Interventions

DRUG

Lenalidomide

25mg od, dose reduction according to toxicity

DRUG

Lenalidomide

start with 5mg od and increase of dosage to 10mg, 15mg or 25mg until CRP response (50% decrease)

OTHER

basic cachexia management (prokinetics, physical activity counselling, nutritional counselling)

twice during study

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Florian Strasser, MD ABHPM

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • Switzerland

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01127386 on ClinicalTrials.gov