Clinical Trial: Regimen for the Treatment of Cachexia in Subjects With NSCLC
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary:
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.
Sponsor: Vicus Therapeutics
Current Primary Outcome:
- Proportion of Subjects With a Positive Change From Baseline to Week 4 in Lean Body Mass [ Time Frame: 4 weeks ]
- Proportion of Subjects With a Positive Change From Baseline to Week 4 in Grip Strength [ Time Frame: 4 weeks ]
Original Primary Outcome: Dose tolerance efficacy [ Time Frame: One Year ]
Current Secondary Outcome:
Original Secondary Outcome: Quality of life and weight gain [ Time Frame: One Year ]
Information By: Vicus Therapeutics
Dates:
Date Received: August 30, 2007
Date Started: January 2007
Date Completion:
Last Updated: December 19, 2012
Last Verified: December 2012
