Clinical trial NCT00527319: Regimen for the Treatment of Cachexia in Subjects With NSCLC
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cachexia
Keywords: NSCLC
anorexia
cachexia
grip strength
lean body mass
Lead sponsor: Vicus Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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 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

Primary outcomes:
measure: Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass
timeFrame: 4 weeks
measure: Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Waco
country: United States
facility: First Dynamic Health Care Services, Inc.
state: Texas
city: Bangalore
country: India
facility: Rajalakshmi Nursing Home
city: Hyderabaad
country: India
facility: Nizam Institute of Medical Sciences
city: Kolkata
country: India
facility: Orchid Nursing Home
city: Nashik
country: India
facility: Shatabdi Super Specialty Hospital
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: New Delhi
country: India
facility: Indraprastha Apollo Hospital
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital
Study officials:
affiliation: Oxford Pharmaceutical Resources, Inc.
name: Richard A Guarino, MD
role: STUDY_DIRECTOR
References: