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.
The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
37
VT-122 low dose, dose escalated
VT-122 high dose, dose escalated
First Dynamic Health Care Services, Inc.
Waco, Texas, United States
Rajalakshmi Nursing Home
Bangalore, India
Nizam Institute of Medical Sciences
Hyderabaad, India
Orchid Nursing Home
Kolkata, India
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
Time frame: 4 weeks
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
Time frame: 4 weeks
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Shatabdi Super Specialty Hospital
Nashik, India
All India Institute of Medical Sciences
New Delhi, India
Indraprastha Apollo Hospital
New Delhi, India
Deenanath Mangeshkar Hospital
Pune, India