Study of Ruxolitinib in the Treatment of Cachexia in Patients With Tumor-Associated Chronic Wasting Diseases.
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ClinicalTrials.gov Identifier: NCT02072057
Recruitment Status :
Active, not recruiting
First Posted : February 26, 2014
Last Update Posted : June 6, 2017
Clinical Trial Unit, University Hospital Basel, Switzerland
The aim of this study is to investigate the effects and safety of Ruxolitinib, a Janus kinase 1 (JAK1) and Janus kinase 2 (JAK2) inhibitor for the treatment of tumor-associated cachexia in chronic wasting diseases.
Body weight [ Time Frame: Baseline. 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months ]
Lean Body (muscle) Mass (LBM) [ Time Frame: Baseline. 3, 6, and 12 months ]
Dual energy X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA)
Resting energy expenditure (REE) [ Time Frame: Baseline. 3, 6, and 12 months ]
Activity Energy Expenditure (AEE) [ Time Frame: Baseline. 3, 6, and 12 months ]
Body mass index (BMI) [ Time Frame: Baseline. 3, 6, and 12 months ]
Formula BMI = W / H2 (W=body weight in kilograms; H=body height in meters)
Tumor assessment [ Time Frame: Baseline. 6, and 12 months ]
Clinical and radiological (CT or MRI)
Grip Strength [ Time Frame: Baseline. 3, 6, and 12 months ]
Grip Strength measured by dynamometer
Quality of Life [ Time Frame: Baseline. 1, 2, 3, 6, 9, and 12 months ]
Nutritional history [ Time Frame: Baseline. After 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months ]
Nutritional Risk Screening Tool
Number of adverse events [ Time Frame: Up to 24 months ]
Reporting of adverse events according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Stair climbing test [ Time Frame: Baseline. 3, 6, and 12 months ]
Measurement of power and speed on a stair climbing test (Stair climb speed [m/sec]=[height of 12 steps(meters)]/[time (seconds) up the 12 steps]; Stair climb power [watts]=[9.8 m/sec2]*[weight (kg)]*[height of 12 steps(meters)]/[time (seconds) up the 12 steps]).
Other Outcome Measures:
Cytokines levels [ Time Frame: Baseline. 1, 2, 3, 4, 5, 6, and 12 months ]
Multiplex-assays for proinflammatory cytokines
Reactive oxygen species (ROS) levels [ Time Frame: Baseline. 1, 2, 3, 4, 5, 6, and 12 months ]
Free oxygen radical monitor (FORM) with proper kits (FORMOX with FORT and FORD analysis kits, Callegari 1930 S.P.A., Parma, Italy).
JAK/STAT pathway activation [ Time Frame: Baseline. 1, 2, 3, 4, 5, 6, and 12 months ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Definition of cachexia (see Section 11.1) fulfilled
Age ≥ 18 years
Confirmed tumor of any site
Life expectancy of ≥3 months
Subject must be willing to receive transfusion of blood products
Patient must give written informed consent
Females of childbearing potential (FCBP) must undergo pregnancy testing (serum) and pregnancy result must be negative.*
Reliable contraception should be maintained throughout the study and for 28 days after study treatment discontinuation
Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods
Males (including those who have had a vasectomy) must use barrier contraception (condoms) when engaging in sexual activity with FCBP. Males must agree not to donate semen or sperm
Pregnant or breast feeding females
Lack of written informed consent
No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.
No consent for "Translational Research" and "Biobanking" (see separate documents "Aufbewahrung und Weiterverwendung von biologischem Material und von Daten für die biomedizinische Forschung" und "Biobankreglement" for the RUXexia Trial).
Thrombocytopenia < 50 x 10e9/l
Peroral intake not possible, in particular by stenosis of the esophagus
New started treatment of the tumor (first 3 months of a new treatment). Patients with a new treatment of the cancer disease should delay screening/enrollment until 3 months after start of this treatment.
Presence of any medical/psychiatric condition or laboratory abnormalities which may limit full compliance with the study, increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
Patients with a Myeloproliferative Neoplasm
Patients receiving any "Prohibited Medications" (see protocol) within 7 days prior to the first dose of study drug
Patients with clinically significant bacterial, fungal, parasitic or viral infection which require therapy. Patients with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.