Regimen for the Treatment of Cachexia in Subjects With NSCLC
VT-122
A Pilot Open Label Randomized Controlled Study to Evaluate the Dose Tolerance Safety and Efficacy of VT-122 Regimen for the Treatment of Cachexia in Subjects With Stage IV Non-Small Cell Lung Cancer
1 other identifier
interventional
37
2 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2007
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 30, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
January 30, 2013
CompletedJanuary 30, 2013
December 1, 2012
1.6 years
August 30, 2007
November 8, 2012
December 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Group A, control group
NO INTERVENTIONSupportive care only
Group B, Low Dose VT-122
ACTIVE COMPARATORVT-122 (dose of etodolac: 400 mg/day) + supportive care
Group C, High Dose VT-122
ACTIVE COMPARATORVT-122 (dose of etodolac: 800 mg/day) + supportive care
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
First Dynamic Health Care Services, Inc.
Waco, Texas, 76708, United States
Rajalakshmi Nursing Home
Bangalore, India
Nizam Institute of Medical Sciences
Hyderabaad, India
Orchid Nursing Home
Kolkata, India
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Richard Guarino
- Organization
- Oxford Pharmaceutical Resources, Inc.
Study Officials
- STUDY DIRECTOR
Richard A Guarino, MD
Oxford Pharmaceutical Resources, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2007
First Posted
September 10, 2007
Study Start
January 1, 2007
Primary Completion
August 1, 2008
Study Completion
September 1, 2008
Last Updated
January 30, 2013
Results First Posted
January 30, 2013
Record last verified: 2012-12