The Role of Ghrelin in Cancer Cachexia
| Status: | Terminated |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/19/2018 |
| Start Date: | June 2012 |
| End Date: | March 2016 |
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
