Clinical Trial: Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of repeated oral administration of macimorelin at different doses daily for 1 week for the treatment of cancer cachexia.
Detailed Summary:
Sponsor: Garcia, Jose M., MD, PhD
Current Primary Outcome:
- Change of body weight [ Time Frame: 7 days ]The change of body weight(kg)will be measured between day 1 and day 7.
- Change of IGF-1 plasma levels [ Time Frame: 7 days ]The change of IGF-1 plasma levels will be measured between day 1 (prior to dosing) and day 7.
- Change of quality of life score [ Time Frame: 7 days ]The change of quality of life score (Anderson Symptom Assessment Scale, FACIT-F) will be measured between day 1 and day 7.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Food Intake and Diary [ Time Frame: 7 days ]Food intake as measured by a food diary to be recorded for 3 days before days 1 and 7 and by a test meal done at screening and on day 7.
- Appetite [ Time Frame: 7 days ]Change of appetite measured by a validated visual analogue scale between day 1 and day 7.
- Body Composition [ Time Frame: 7 days ]Body composition as measured by bio-impedance and dual-energy x-ray absorptiometry on days 1 and 7.
- Muscle strength [ Time Frame: 7 days ]Muscle strength as measured by handgrip strength and stair climbing power.
- Energy expenditure as measured by indirect calorimetry. [ Time Frame: 7 days ]Energy expenditure as measured by indirect calorimetry.
- Laboratory Assays [ Time Frame: 7 days ]Change in IGFBP-3, GH, CRP, IL-6, TNF-α and glucose between day 1 and day 7.
- fMRI [ Time Frame: 7 days ]Changes in reward from food as measured by brain functional Magnetic Resonance Imaging (fMRI).
- Functional Brain Connectivity [ Time Frame: 7 days ]Changes in functional brain connectivity as assessed by Resting State Functional Connectivity (RSFC) imaging and Diffusion Tensor Imaging (DTI).
- Safety Laboratory [ Time Frame: 7 days ]Clinical laboratory parameters: complete blood count (CBC), comprehensive metabolic panel (CMP), urinalysis (UA)
- Vital signs [ Time Frame: 7 days ]
- ECG [ Time Frame: 7 days ]Electrocardiogram (ECG) at days 1 and 7 before and 1 hour after dosing and on the post-study visit.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 7 days ]Recording of any adverse events from day 1 to day 7.
Original Secondary Outcome:
- Food Intake and Diary [ Time Frame: 7 days ]Food intake as measured by a food diary to be recorded for 3 days before days 1 and 7 and by a test meal done at screening and on day 7.
- Appetite [ Time Frame: 7 days ]Change of appetite measured by a validated visual analogue scale between day 1 and day 7.
- Body Composition [ Time Frame: 7 days ]Body composition as measured by bio-impedance on days 1 and 7.
- Muscle strength [ Time Frame: 7 days ]Muscle strength as measured by handgrip strength and stair climbing power.
- Energy expenditure as measured by indirect calorimetry. [ Time Frame: 7 days ]Energy expenditure as measured by indirect calorimetry.
- Laboratory Assays [ Time Frame: 7 days ]Change in IGFBP-3, GH, CRP, IL-6, TNF-α and glucose between day 1 and day 7.
- fMRI [ Time Frame: 7 days ]Changes in reward from food as measured by brain functional Magnetic Resonance Imaging (fMRI).
- Functional Brain Connectivity [ Time Frame: 7 days ]Changes in functional brain connectivity as assessed by Resting State Functional Connectivity (RSFC) imaging and Diffusion Tensor Imaging (DTI).
- Safety Laboratory [ Time Frame: 7 days ]Clinical laboratory parameters: complete blood count (CBC), comprehensive metabolic panel (CMP), urinalysis (UA)
- Vital signs [ Time Frame: 7 days ]
- ECG [ Time Frame: 7 days ]Electrocardiogram (ECG) at days 1 and 7 before and 1 hour after dosing and on the post-study visit.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 7 days ]Recording of any adverse events from day 1 to day 7.
Information By: Garcia, Jose M., MD, PhD
Dates:
Date Received: June 5, 2012
Date Started: May 2012
Date Completion: December 2017
Last Updated: May 2, 2017
Last Verified: May 2017