Regimen for the Treatment of Cachexia in Subjects With NSCLC

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group B, Low Dose VT-122	VT-122 low dose	VT-122 (dose of etodolac: 400 mg/day) + supportive care
Group C, High Dose VT-122	VT-122 high dose	VT-122 (dose of etodolac: 800 mg/day) + supportive care

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass	4 weeks
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength	4 weeks

Secondary Outcome Measures

Name	Time	Method

Locations (8): Orchid Nursing Home
🇮🇳
Kolkata, India
All India Institute of Medical Sciences
🇮🇳
New Delhi, India
Nizam Institute of Medical Sciences
🇮🇳
Hyderabaad, India
Shatabdi Super Specialty Hospital
🇮🇳
Nashik, India
Deenanath Mangeshkar Hospital
🇮🇳
Pune, India
Indraprastha Apollo Hospital
🇮🇳
New Delhi, India
First Dynamic Health Care Services, Inc.
🇺🇸
Waco, Texas, United States
Rajalakshmi Nursing Home
🇮🇳
Bangalore, India