Clinical Trial: The Role of Ghrelin in Cancer Cachexia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Role of Ghrelin in Cancer Cachexia

Brief Summary:

Cancer is often coupled with a condition called cachexia. In this condition, individuals continue to lose weight and lean body mass, which means their muscles are getting smaller and weaker. Studies have shown that cancer patients who are losing weight often are responding poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy. Also, people may not want to eat. To date, there are no approved treatments available for this condition.

This study is going to study the benefits of the use of the study drug, Anamorelin hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies done before with the study drug have shown that the drug can help the cachectic condition. The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including measurements of body potassium and nitrogen stores.

In addition to the above, the study will also assess the effect of the study drug on handgrip strength, body weight, lean muscle mass, quality of life, appetite & food intake, certain blood markers, energy expenditure (the amount of energy participants burn), functional performance, safety and tolerability of Anamorelin HCl.


Detailed Summary: Subjects enrolled in the study will be randomly chosen to receive either Anamorelin HCL at a dose of 100 mg per day for 12 weeks or matching placebo. The chances of receiving anamorelin or placebo are 1 in 2. Which subject receives anamorelin or placebo will be decided at random. Neither the subject nor the study doctor will know which study drug the subject is receiving. The subject will be asked to visit the clinic at Day 1, Day 28, Day 56 and Day 84. There will also be a Day 112 follow-up visit and the medical records will be checked after that to see how the subjects are doing.
Sponsor: VA Office of Research and Development

Current Primary Outcome: Total Body Potassium. [ Time Frame: 2 years ]

Original Primary Outcome: Total Body Potassium. [ Time Frame: two years ]

Current Secondary Outcome:

  • Body Composition as Measured by Densitometry. [ Time Frame: 2 years ]
  • Muscle Strength as Measured by Grip Strength. [ Time Frame: 2 years ]
  • Body Weight. [ Time Frame: 2 years ]
  • Quality of Life. [ Time Frame: 2 years ]
    Quality of life as assessed using the Assessment SpondyloArthritis (ASAS), EuroQol five dimensions questionnaire (EQ-5D) and FACIT-F, Patient Reported Outcome assessments
  • Appetite. [ Time Frame: 2 years ]
    Appetite measured by a visual analogue scale and a food diary.
  • Resting Energy Expenditure. [ Time Frame: 2 years ]
  • Functional Performance. [ Time Frame: 2 years ]
    Functional performance using stair-climbing power, 6-minute walk, tests of the major muscle groups and 24 hour physical activity levels
  • Body Composition. [ Time Frame: 2 years ]
    Body composition as measured by Total body nitrogen and bioimpedance.
  • Safety and Tolerability. [ Time Frame: 2 years ]
    The safety and tolerability of Anamorelin HCl assessed through the number of participants with Adverse Events.


Original Secondary Outcome:

  • Body Composition as Measured by Densitometry. [ Time Frame: 2 years ]
  • Muscle Strength as Measured by Grip Strength. [ Time Frame: two years ]
  • Body Weight. [ Time Frame: two years ]
  • Quality of Life. [ Time Frame: Two years ]
    Quality of life as assessed using the ASAS, EQ-5D and FACIT-F, Patient Reported Outcome assessments
  • Appetite. [ Time Frame: two years ]
    Appetite measured by a visual analogue scale and a food diary.
  • Resting Energy Expenditure. [ Time Frame: two years ]
  • Functional Performance. [ Time Frame: two years ]
    Functional performance using stair-climbing power, 6-minute walk, tests of the major muscle groups and 24 hour physical activity levels
  • Body Composition. [ Time Frame: two years ]
    Body composition as measured by Total body nitrogen and bioimpedance.
  • Safety and Tolerability. [ Time Frame: two years ]
    The safety and tolerability of Anamorelin HCl assessed through the number of participants with Adverse Events.
  • Biomarkers TNF-alpha, IL-6, IGF-1 and IGFBP-3. [ Time Frame: two years ]


Information By: VA Office of Research and Development

Dates:
Date Received: December 7, 2011
Date Started: June 2012
Date Completion:
Last Updated: January 5, 2017
Last Verified: January 2017