- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00527319
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Bangalore, India
- Rajalakshmi Nursing Home
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Hyderabaad, India
- Nizam Institute of Medical Sciences
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Kolkata, India
- Orchid Nursing Home
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Nashik, India
- Shatabdi Super Specialty Hospital
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New Delhi, India
- All India Institute of Medical Sciences
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New Delhi, India
- Indraprastha Apollo Hospital
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Pune, India
- Deenanath Mangeshkar Hospital
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-
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Texas
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Waco, Texas, United States, 76708
- First Dynamic Health Care Services, Inc.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group A, control group
Supportive care only
|
|
Active Comparator: Group B, Low Dose VT-122
VT-122 (dose of etodolac: 400 mg/day) + supportive care
|
VT-122 low dose, dose escalated
|
Active Comparator: Group C, High Dose VT-122
VT-122 (dose of etodolac: 800 mg/day) + supportive care
|
VT-122 high dose, dose escalated
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
Time Frame: 4 weeks
|
4 weeks
|
Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Richard A Guarino, MD, Oxford Pharmaceutical Resources, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VT-1 CAX-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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