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The Role of Ghrelin in Cancer Cachexia

Primary Purpose

Cancer Cachexia

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anamorelin HCl
Placebo
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Cachexia focused on measuring Cachexia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1 (Anamorelin HCl)

Arm 2 (Placebo)

Arm Description

Anamorelin HCl

Placebo

Outcomes

Primary Outcome Measures

Total Body Potassium.
percentage change from baseline

Secondary Outcome Measures

Lean Mass Measured by Densitometry.
lean body mass measured by DEXA. Percentage of change day 84-baseline.
Muscle Strength as Measured by Grip Strength.
Dominant hand grip strength day 84 - percent change from baseline
Body Weight.
percent change from day 84-baseline
Quality of Life.
Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments - percentage of change day 84-baseline
Appetite.
Appetite measured by a visual analogue scale ASAS. Percentage of change day84-baseline
Resting Energy Expenditure.
% change between day 84 and baseline
Functional Performance.
Functional performance using stair-climbing power day 84 percent change from baseline
Body Composition.
Body composition as measured by Total body nitrogen. Percentage of change day 84-baseline
Stair Climbing Power
Percent change from baseline
1-repetition Max. Strength
leg extension - percentage of change day 84 to baseline
Food Diary Calorie Count
change between day 84 and baseline

Full Information

First Posted
December 7, 2011
Last Updated
June 22, 2018
Sponsor
VA Office of Research and Development
Collaborators
Helsinn Therapeutics (U.S.), Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01505764
Brief Title
The Role of Ghrelin in Cancer Cachexia
Official Title
The Role of Ghrelin in Cancer Cachexia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Helsinn Therapeutics (U.S.), Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Cachexia
Keywords
Cachexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (Anamorelin HCl)
Arm Type
Experimental
Arm Description
Anamorelin HCl
Arm Title
Arm 2 (Placebo)
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Anamorelin HCl
Intervention Description
100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Total Body Potassium.
Description
percentage change from baseline
Time Frame
day 84
Secondary Outcome Measure Information:
Title
Lean Mass Measured by Densitometry.
Description
lean body mass measured by DEXA. Percentage of change day 84-baseline.
Time Frame
day 84
Title
Muscle Strength as Measured by Grip Strength.
Description
Dominant hand grip strength day 84 - percent change from baseline
Time Frame
day 84
Title
Body Weight.
Description
percent change from day 84-baseline
Time Frame
day 84
Title
Quality of Life.
Description
Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments - percentage of change day 84-baseline
Time Frame
day 84
Title
Appetite.
Description
Appetite measured by a visual analogue scale ASAS. Percentage of change day84-baseline
Time Frame
day 84
Title
Resting Energy Expenditure.
Description
% change between day 84 and baseline
Time Frame
day 84
Title
Functional Performance.
Description
Functional performance using stair-climbing power day 84 percent change from baseline
Time Frame
day 84
Title
Body Composition.
Description
Body composition as measured by Total body nitrogen. Percentage of change day 84-baseline
Time Frame
day 84
Title
Stair Climbing Power
Description
Percent change from baseline
Time Frame
day 84
Title
1-repetition Max. Strength
Description
leg extension - percentage of change day 84 to baseline
Time Frame
day 84
Title
Food Diary Calorie Count
Description
change between day 84 and baseline
Time Frame
day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose M. Garcia, MD PhD
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Role of Ghrelin in Cancer Cachexia

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