CompletedPhase 1/2

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

Switzerland200 participantsStarted 2009-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age: Patients must be older than 18 years of age.
. Tumour situation: Patients with any type of advanced (defined as locally recurrent or metastatic), incurable solid tumour.
. Cachexia: Presence of CCS, defined as involuntary loss of weight of ≥2% in 2 months or ≥5% in 6 months, which is ongoing in the last 4 weeks, and lack of fluid retention.
. Inflammation: CRP must be ≥ 30mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder.
. No simple starvation: Patients must be able to eat, defined as no severe structural barriers in the upper gastrointestinal tract and no bowel obstruction.
. Life expectancy, physical performance: Patient must have an expected life expectancy \> 3 months according to palliative performance (Pap) score and a WHO performance status (PS) ≤ 2.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lean Body Mass

Timeframe: after 8 weeks treatment

and Handgrip Strength

Timeframe: after 8 weeks treatment

Trial details

NCT IDNCT01127386

SponsorFlorian Strasser, MD ABHPM

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-09

View on ClinicalTrials.gov More Cancer Cachexia Syndrome trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age: Patients must be older than 18 years of age.
. Tumour situation: Patients with any type of advanced (defined as locally recurrent or metastatic), incurable solid tumour.
. Cachexia: Presence of CCS, defined as involuntary loss of weight of ≥2% in 2 months or ≥5% in 6 months, which is ongoing in the last 4 weeks, and lack of fluid retention.
. Inflammation: CRP must be ≥ 30mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder.
. No simple starvation: Patients must be able to eat, defined as no severe structural barriers in the upper gastrointestinal tract and no bowel obstruction.
. Life expectancy, physical performance: Patient must have an expected life expectancy \> 3 months according to palliative performance (Pap) score and a WHO performance status (PS) ≤ 2.

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria