Regimen for the Treatment of Cachexia in Subjects With NSCLC - Full Text View

Sponsor:	Vicus Therapeutics
Information provided by:	Vicus Therapeutics
ClinicalTrials.gov Identifier:	NCT00527319

Purpose

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 NSCLS who have hypercatabolic cachexia.

Condition	Intervention	Phase
Cachexia	Drug: VT-122 low dose Drug: VT-122 high dose	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Dose Comparison, Factorial Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Vicus Therapeutics:

Primary Outcome Measures:

Dose tolerance efficacy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Quality of life and weight gain [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	37
Study Start Date:	January 2007
Study Completion Date:	September 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: No Intervention Nutritional support only
B: Active Comparator	Drug: VT-122 low dose VT-122, dose escalated
C: Active Comparator	Drug: VT-122 high dose VT-122 high dose, dose escalated

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527319

Locations

United States, Texas
First Dynamic Health Care Services, Inc.
Waco, Texas, United States, 76708
India
Deenanath Mangeshkar Hospital
Pune, India
Orchid Nursing Home
Kolkata, India
Nizam Institute of Medical Sciences
Hyderabaad, India
Shatabdi Super Specialty Hospital
Nashik, India
Indraprastha Apollo Hospital
New Delhi, India
Rajalakshmi Nursing Home
Bangalore, India
All India Institute of Medical Sciences
New Delhi, India

Sponsors and Collaborators

Vicus Therapeutics

Investigators

Study Director:

Richard A Guarino, MD

Oxford Pharmaceutical Resources, Inc.

More Information

No publications provided

Responsible Party:	Oxford Pharmaceutical Resources, Inc. ( Richard A. Guarino, MD )
Study ID Numbers:	VT-1 CAX-001
Study First Received:	August 30, 2007
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00527319 History of Changes
Health Authority:	United States: Food and Drug Administration; India: Ministry of Health

Keywords provided by Vicus Therapeutics:

NSCLC
anorexia
cachexia
grip strength
lean body mass

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Weight Loss

Body Weight Changes
Cachexia
Emaciation

ClinicalTrials.gov processed this record on November 09, 2009