Clinical Trial: Study of Ruxolitinib in the Treatment of Cachexia in Patients With Tumor-Associated Chronic Wasting Diseases.

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: The RUXexia Trial: An Open-label Phase II Trial of Ruxolitinib in the Treatment of Cachexia in Patients With Tumor-Associated Chronic Wasting Diseases.

Brief Summary: 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.

Detailed Summary:

Cachexia is a multifactorial syndrome characterized by tissue wasting, loss of body weight, particularly of lean body (muscle) mass (LBM) and to a lesser extent adipose tissue, metabolic alterations, fatigue, reduced performance status, and very often accompanied by anorexia leading to a reduced food intake. Cachexia accompanies the end stage of many chronic diseases and especially cancer and therefore is also termed "cancer-related anorexia/cachexia syndrome" (CACS). Clinically, cachexia is defined as an unintentional 5% resp. 10% loss of body weight over a 6-month resp. 12-month period that is directly associated with an underlying disease. The progressive loss of adipose tissue and skeletal muscle despite adequate feeding results in weakness, reduced ambulation, diminished quality of life, poor response to therapy, and often death due to respiratory failure or infection. At the time of cancer diagnosis, 80% of patients with upper gastrointestinal cancers and 60% of patients with lung cancer have already had substantial weight loss. Currently, there are no approved effective treatments for the treatment of cachexia. Understanding the molecular mechanisms responsible for muscle wasting is necessary to develop targeted therapies that play a central role in signal transduction initiated by cytokines (e.g., interleukin and interferon signaling), growth factors, and hormones for these most vulnerable patients. Key features of CACS are increased resting energy expenditure (REE), increased levels of circulating factors produced by the host immune system in response to the tumor, such as proinflammatory cytokines, or by the tumor itself, such as proteolysis-inducing factor. Inflammation is a unifying mechanism for the entire cluster of sickness behaviours (asthenia, increased slow-wave sleep, mood alteration, lethargy, depression, anorexia, fever, anhedonia, cognitive impairment, hyperalgesia and decreased social int
Sponsor: Kantonsspital Aarau

Current Primary Outcome: Body weight [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    Indirect calorimetry
  • Activity Energy Expenditure (AEE) [ Time Frame: Baseline. 3, 6, and 12 months ]
    AEE-Questionnaires
  • 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 ]
    EORTC-QLQ-C30 questionnaire
  • 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]).


Original Secondary Outcome: Same as current

Information By: Kantonsspital Aarau

Dates:
Date Received: February 21, 2014
Date Started: April 2014
Date Completion: April 2018
Last Updated: February 24, 2016
Last Verified: February 2016