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The Role of Ghrelin in Cancer Cachexia

NCT01505764 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-07-17

Study results available
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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.

Conditions

  • Cancer Cachexia

Interventions

DRUG

Anamorelin HCl

100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.

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.

Sponsors & Collaborators

  • Helsinn Therapeutics (U.S.), Inc

    collaborator INDUSTRY

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Jose M. Garcia, MD PhD · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01505764 on ClinicalTrials.gov