Regimen for the Treatment of Cachexia in Subjects With NSCLC
Condition: Cachexia
MeSH terms: Wasting Syndrome; Cachexia
Intervention: VT-122 low dose; VT-122 high dose
Intervention description: VT-122 low dose, dose escalated; VT-122 high dose, dose escalated
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; anorexia; cachexia; grip strength; lean body mass

Summary:

      Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a
      hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are
      not functioning and increased nutrition is not utilized.

      To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy
      must block multi-factorial stress signaling a threshold of activation. Consistent with the
      synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with
      advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of
      VT-122 in subjects with NSCLC who have hypercatabolic cachexia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with NSCLC

          -  Demonstrating average weight loss of 5% within 2 months prior to enrollment

          -  Heart rate of 72 bpm or greater

          -  Negative pregnancy test (female patients of child bearing age)

          -  Able to give informed consent

          -  Able to be administered medication

          -  Able to take food and defined nutritional support

          -  Have not been on beta-blockers for a minimum of 1 week prior to administration of the
             medication screening dose

          -  Have not undergone surgery for at least 2 weeks prior to entry into trial

          -  Have not been on chemotherapy, immunotherapy, biologic therapy, radio therapy, and
             experimental therapy for a minimum of two weeks prior to medication screening dose and
             during their participation in this trial

          -  An expected survival for a minimum of 12 weeks

        Exclusion Criteria:

          -  Contraindication to nonsteroidal antiinflammatory drugs (NSAIDs) and beta blockers

          -  Blood pressure less than 100/65

          -  Weight loss of 15% within 2 months prior to recruitment

          -  Hypersensitivity reaction to the active components in VT-122

          -  History of myocardial infraction within the past 3 months

          -  Congestive heart failure (as determined by symptoms and ECG)

          -  A-V block of second or third degree

          -  Unstable angina

          -  Uncontrolled diabetes

          -  Unable to be assessed for grip strength

          -  A positive pregnancy test

          -  Chronic infection or sepsis

          -  History of bleeding disorders

          -  Patients with peripheral edema

          -  Patients on digoxin or other chronotropic drugs

          -  Patients with evidence of severe dehydration

          -  Patients with evidence of ascites