Cancer Cachexia SyndromePhase 1/2NCT01127386
Lenalidomide for Lean Body Mass and Muscle Strength in Inflammatory Cancer Cachexia Syndrome
A Phase 1/2 study testing Lenalidomide and basic cachexia management (prokinetics, physical activity counselling, nutritional counselling) in people with Cancer Cachexia Syndrome, run by Florian Strasser, MD ABHPM at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Cachexia Syndrome
- What is being tested?
- Lenalidomide and basic cachexia management (prokinetics, physical activity counselling, nutritional counselling)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2009to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- No anti-cachexia or appetite-stimulating medications: Patients are not allowed to have corticosteroids unless for maximum 2 days per week for chemotherapy, progestin therapy, Cyclooxigenase-2 inhibitor (COX-2 inhibitor), and anabolic drugs 28 days before start of trial medication until study conclusion. Prokinetic medication, NSAR, paracetamol and novamin sulphate are allowed, if given in a fixed dose for two weeks before visit 1, and expected to be given during the whole trial period.
- Laboratory test results: Granulocyte count ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, serum creatinine ≤ 2.0 mg/dL (177 μmol/L), creatinine clearance ClCr ≥ 50ml/min, total bilirubin ≤1.5 mg/dL (25μmol/L), and AST (SGOT)/ ALT (SGPT) ≤2 x ULN or if hepatic metastases are present ≤ 5 x ULN.
- No other trial: Patient is not participating any other clinical intervention 28 days before start of trial medication until study conclusion.
- Women of childbearing potential (see Annex 1): A negative pregnancy test \& effective contraception are mandatory in child-bearing age.
- A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- A FCBP potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mU/mL within 10 to 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.
- FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See (Annex 2): Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
- Cognition: Presence of a normal level of consciousness (mandatory is a normal abbreviated screening mini-mental test or a common mini-mental ≥ 27/30; in elderly patients age ≥ 65 years or patients with low education a mini mental status of ≥25/30 points will be considered adequate).
- Logistics: The patient is able to comply with the study schedule and procedures (including fasting for blood draws on certain visits)
- Consent: The patient has voluntarily signed and dated the informed consent (IC), approved by the Ethics Committee (EC), prior to any study-specific procedures.
- Will consent to the use of asprin (100mg) or low molecular weight heparin (if intolerant to aspirin) in prophylactic dose (e.g. Fragmin 2500U sc od).
- Study participant agrees to be registered in the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.(Appendix 18)
Who cannot join
- Untreated secondary causes of cachexia (oral thrush, nausea, vomiting, constipation, diarrhoea, pain VAS>3, depression, dyspnoea)
- CTCAEv3.0 ≥ grade 2 due to anticancer treatment (chemotherapy, radiotherapy or surgery)
- Any psychiatric disorder, alcohol and illicit drug abuse or language problem that would prevent the patient from filling in the questionnaires adequately or attend study visits according to protocol.
- Parenteral nutrition
- Presence of dysthyreosis, defined as TSH beyond normal ranges
- Presence of long QT syndrome or QTc > 450ms or under treatment with a QT prolonging drug
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- Presence of lactose intolerance
- Diabetes mellitus with secondary organ dysfunction (coronary heart disease, previous stroke, renal insufficiency)
- Patients with cerebral metastases or prophylactic whole brain irradiation for possible cerebral metastases.
- Known hypersensitivity to thalidomide or a history of development of erythema nodosum due to thalidomide or similar drugs.
- Any prior use of lenalidomide
- Known infection with HIV, hepatitis B or C
- Patients with known myeloid malignancy or tumours having bone marrow involvement.
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent (IC) form.
- Pregnant or breastfeeding females.
Trial locations and contacts
1 site in 1 country.
About this study
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-concept Study of Fixed Dose or CRP-response-guided Dose of Lenalidomide in Relation to New Standard Basic Cachexia Management (Receiving Placebo).
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
- Being tested
- Lenalidomide, basic cachexia management (prokinetics, physical activity counselling, nutritional counselling)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
25mg od, dose reduction according to toxicity
LenalidomideDrug
Also called Revlimid
start with 5mg od and increase of dosage to 10mg, 15mg or 25mg until CRP response (50% decrease)
basic cachexia management (prokinetics, physical activity counselling, nutritional counselling)Other
twice during study
| Study group | Role | What they receive |
|---|---|---|
| fix dose lenalidomide 25mg, basic cachexia management | Experimental | dose reduction according to toxicity possible Receives: Drug: Lenalidomide |
| 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) Receives: Drug: Lenalidomide |
| placebo | Experimental | to generate data about basic cachexia management, no direct comparator for treatment arms efficacy Receives: Other: basic cachexia management (prokinetics, physical activity counselling, nutritional counselling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean Body Mass
Measured: after 8 weeks treatment
and Handgrip Strength
Measured: after 8 weeks treatment
Secondary outcomes (6)
SAEs
Measured: for 12 weeks
nutritional intake
Measured: after 8 weeks of treatment
physical functioning
Measured: after 8 weeks of treatment
inflammation
Measured: for 8 weeks
eating related symptoms (FAACT)
Measured: after 8 weeks of treatment
tumour dynamics (CT)
Measured: after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMar 2009
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Cachexia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florian Strasser, MD ABHPM
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene
- Responsible party
- Sponsor-investigator, Florian Strasser, MD ABHPM, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127386
- Sponsor's protocol ID
- EKSG 09/040
- Status last verified
- Jul 2017
- First submitted
- 12 May 2010
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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-concept Study of Fixed Dose or CRP-response-guided Dose of Lenalidomide in Relation to New Standard Basic Cachexia Management (Receiving Placebo).
- ClinicalTrials.gov ID
- NCT01127386
- Acronym / sponsor ID
- EKSG 09/040
- Conditions
- Cancer Cachexia Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Florian Strasser, MD ABHPMUniversity, hospital or other
- Collaborators
- Celgene
- Study start
- Mar 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fix dose lenalidomide 25mg, basic cachexia management | Experimental | Drug: Lenalidomidedose reduction according to toxicity possible |
| CRP-response guided lenalidomide, basic cachexia management | Experimental | Drug: Lenalidomidestart with 5mg od and increase of dosage to 10mg, 15mg or 25mg until CRP response (50% decrease) |
| placebo | Experimental | Other: basic cachexia management (prokinetics, physical activity counselling, nutritional counselling)to generate data about basic cachexia management, no direct comparator for treatment arms efficacy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (16 listed)
- Untreated secondary causes of cachexia (oral thrush, nausea, vomiting, constipation, diarrhoea, pain VAS>3, depression, dyspnoea)
- CTCAEv3.0 ≥ grade 2 due to anticancer treatment (chemotherapy, radiotherapy or surgery)
- Any psychiatric disorder, alcohol and illicit drug abuse or language problem that would prevent the patient from filling in the questionnaires adequately or attend study visits according to protocol.
- Parenteral nutrition
- Presence of dysthyreosis, defined as TSH beyond normal ranges
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: Revlimid25mg od, dose reduction according to toxicity | Drug | fix dose lenalidomide 25mg, basic cachexia management |
| LenalidomideAlso: Revlimidstart with 5mg od and increase of dosage to 10mg, 15mg or 25mg until CRP response (50% decrease) | Drug | CRP-response guided lenalidomide, basic cachexia management |
| basic cachexia management (prokinetics, physical activity counselling, nutritional counselling)twice during study | Other | placebo |
Primary outcome
Lean Body Mass
Time frame: after 8 weeks treatment
and Handgrip Strength
Time frame: after 8 weeks treatment
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lenalidomide and basic cachexia management (prokinetics, physical activity counselling, nutritional counselling) in people with Cancer Cachexia Syndrome, run by Florian Strasser, MD ABHPM at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean Body Mass (time frame: after 8 weeks treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.