The Role of Ghrelin in Cancer Cachexia
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|ClinicalTrials.gov Identifier: NCT01505764|
Recruitment Status : Terminated (poor recruitment)
First Posted : January 9, 2012
Results First Posted : February 24, 2017
Last Update Posted : July 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Cachexia||Drug: Anamorelin HCl Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Role of Ghrelin in Cancer Cachexia|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Arm 1 (Anamorelin HCl)
Drug: Anamorelin HCl
100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
Placebo Comparator: Arm 2 (Placebo)
Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
- Total Body Potassium. [ Time Frame: day 84 ]percentage change from baseline
- Lean Mass Measured by Densitometry. [ Time Frame: day 84 ]lean body mass measured by DEXA. Percentage of change day 84-baseline.
- Muscle Strength as Measured by Grip Strength. [ Time Frame: day 84 ]Dominant hand grip strength day 84 - percent change from baseline
- Body Weight. [ Time Frame: day 84 ]percent change from day 84-baseline
- Quality of Life. [ Time Frame: day 84 ]Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments - percentage of change day 84-baseline
- Appetite. [ Time Frame: day 84 ]Appetite measured by a visual analogue scale ASAS. Percentage of change day84-baseline
- Resting Energy Expenditure. [ Time Frame: day 84 ]% change between day 84 and baseline
- Functional Performance. [ Time Frame: day 84 ]Functional performance using stair-climbing power day 84 percent change from baseline
- Body Composition. [ Time Frame: day 84 ]Body composition as measured by Total body nitrogen. Percentage of change day 84-baseline
- Stair Climbing Power [ Time Frame: day 84 ]Percent change from baseline
- 1-repetition Max. Strength [ Time Frame: day 84 ]leg extension - percentage of change day 84 to baseline
- Food Diary Calorie Count [ Time Frame: day 84 ]change between day 84 and baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505764
|United States, Texas|
|Michael E. DeBakey VA Medical Center, Houston, TX|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jose M. Garcia, MD PhD||VA Puget Sound Health Care System Seattle Division, Seattle, WA|