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Regimen for the Treatment of Cachexia in Subjects With NSCLC (VT-122)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00527319
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):
Vicus Therapeutics

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.

Condition or disease Intervention/treatment Phase
Cachexia Drug: VT-122 low dose Drug: VT-122 high dose Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : January 2007
Primary Completion Date : August 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
Drug: VT-122 low dose
VT-122 low dose, dose escalated
Active Comparator: Group C, High Dose VT-122
VT-122 (dose of etodolac: 800 mg/day) + supportive care
Drug: VT-122 high dose
VT-122 high dose, dose escalated

Primary Outcome Measures :
  1. Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass [ Time Frame: 4 weeks ]
  2. Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527319

United States, Texas
First Dynamic Health Care Services, Inc.
Waco, Texas, United States, 76708
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
Sponsors and Collaborators
Vicus Therapeutics
Study Director: Richard A Guarino, MD Oxford Pharmaceutical Resources, Inc.

Responsible Party: Vicus Therapeutics
ClinicalTrials.gov Identifier: NCT00527319     History of Changes
Other Study ID Numbers: VT-1 CAX-001
First Posted: September 10, 2007    Key Record Dates
Results First Posted: January 30, 2013
Last Update Posted: January 30, 2013
Last Verified: December 2012

Keywords provided by Vicus Therapeutics:
grip strength
lean body mass

Additional relevant MeSH terms:
Wasting Syndrome
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders