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The Role of Ghrelin in Cancer Cachexia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01505764
Recruitment Status : Terminated (poor recruitment)
First Posted : January 9, 2012
Results First Posted : February 24, 2017
Last Update Posted : July 17, 2018
Helsinn Therapeutics (U.S.), Inc
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Cancer Cachexia Drug: Anamorelin HCl Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: Arm 1 (Anamorelin HCl)
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)
Drug: 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.

Primary Outcome Measures :
  1. Total Body Potassium. [ Time Frame: day 84 ]
    percentage change from baseline

Secondary Outcome Measures :
  1. Lean Mass Measured by Densitometry. [ Time Frame: day 84 ]
    lean body mass measured by DEXA. Percentage of change day 84-baseline.

  2. Muscle Strength as Measured by Grip Strength. [ Time Frame: day 84 ]
    Dominant hand grip strength day 84 - percent change from baseline

  3. Body Weight. [ Time Frame: day 84 ]
    percent change from day 84-baseline

  4. 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

  5. Appetite. [ Time Frame: day 84 ]
    Appetite measured by a visual analogue scale ASAS. Percentage of change day84-baseline

  6. Resting Energy Expenditure. [ Time Frame: day 84 ]
    % change between day 84 and baseline

  7. Functional Performance. [ Time Frame: day 84 ]
    Functional performance using stair-climbing power day 84 percent change from baseline

  8. Body Composition. [ Time Frame: day 84 ]
    Body composition as measured by Total body nitrogen. Percentage of change day 84-baseline

  9. Stair Climbing Power [ Time Frame: day 84 ]
    Percent change from baseline

  10. 1-repetition Max. Strength [ Time Frame: day 84 ]
    leg extension - percentage of change day 84 to baseline

  11. Food Diary Calorie Count [ Time Frame: day 84 ]
    change between day 84 and baseline

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have incurable, histologically or cytologically documented Non-Small Cell Lung Cancer or Colo-rectal Cancer.
  • Females and males at least 18 years of age.
  • Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) unresectable Stage III or IV NSCLC and/or stage III or IV colorectal cancer (CRC) (not amenable to curative resection).
  • Involuntary weight loss of 5% body weight over a period of 6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status 2 at screening.
  • Estimated life expectancy of greater than 4 months at the time of screening.
  • Presence and functional use of both hands.
  • Able to understand and comply with the procedures of the handgrip strength evaluation.
  • If the patient is a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 28 days following the last dose of study medication.
  • Willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.

Exclusion Criteria:

  • Other forms of lung cancer.
  • Women who are pregnant or breast-feeding.
  • Obesity.
  • Recent active excessive alcohol or illicit drug use current use of marijuana or history of marijuana use over the previous 6 months.
  • Severe depression.
  • Other causes of cachexia such as:

    • Liver disease (AST or ALT > 3x normal levels)
    • Renal failure (creatinine > 2.5 mg/dL)
    • Untreated thyroid disease
    • Class III-IV CHF
    • AIDS
    • Other cancer diagnosed within the past five years other than non-melanoma skin cancer and prostate cancer
    • Severe COPD requiring use of home O2.
  • Inability to increase food intake.
  • Recent administration of highly emetogenic chemotherapy.
  • Known HIV, active hepatitis B or C (with increased LFTs), or active tuberculosis.
  • Patients who have received two prior regimens of cytotoxic chemotherapy and are undergoing, or planning to undergo, a third regimen of cytotoxic chemotherapy.
  • Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to:

    • Testosterone
    • Androgenic compounds
    • Megestrol acetate
    • Methylphenidate
    • Dronabinol
  • Current use of steroids or history of use over the previous 6 months except as pre- and post-medications for chemotherapy administration.
  • Patients unable to readily swallow oral tablets.
  • An active, uncontrolled infection.
  • Uncontrolled diabetes mellitus.
  • Known or suspected brain metastases.
  • Patients receiving strong CYP3A4 inhibitors.
  • Patients receiving tube feedings or parenteral nutrition.
  • Patients with any concomitant medical or psychiatric condition or social situation that would make it difficult to comply with protocol requirements, including the inability to comply with handgrip strength determinations in both hands; for example, pre-existing neurological impairment.
  • Previous exposure to Anamorelin HCl.
  • Patients actively receiving a concurrent investigational agent, or any patients that have received an investigational agent within four weeks prior to randomization.
  • Current use of diuretics or history of intermittent diuretic usage for any reason over the previous 3 months.
  • History of claustrophobia.
  • Cachexia deemed by the investigator to be solely due to chemo or radiation treatment

Information from the National Library of Medicine

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 identifier (NCT number): NCT01505764

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United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Helsinn Therapeutics (U.S.), Inc
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Principal Investigator: Jose M. Garcia, MD PhD VA Puget Sound Health Care System Seattle Division, Seattle, WA
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Responsible Party: VA Office of Research and Development Identifier: NCT01505764    
Other Study ID Numbers: CLIN-013-08F
HT-ANAM-208 ( Other Identifier: Helsinn Therapeutics (U.S.), Inc )
First Posted: January 9, 2012    Key Record Dates
Results First Posted: February 24, 2017
Last Update Posted: July 17, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VA Office of Research and Development:
Additional relevant MeSH terms:
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Wasting Syndrome
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders