Conditions: Cachexia
Keywords: NSCLC anorexia cachexia grip strength lean body mass
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 37
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Supportive care only arm 2: VT-122 (dose of etodolac: 400 mg/day) + supportive care arm 3: VT-122 (dose of etodolac: 800 mg/day) + supportive care

Interventions: intervention 1: VT-122 low dose intervention 2: VT-122 high dose
Intervention descriptions: intervention 1: VT-122 low dose, dose escalated intervention 2: VT-122 high dose, dose escalated

Protocol document: