The Role of Ghrelin in Cancer Cachexia

What Was Tested

In this phase 2 trial, researchers set out to test Anamorelin (non-peptide).

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.

It had two arms (groups): Arm 1 (Anamorelin HCl) (experimental) and Arm 2 (Placebo) (placebo comparator).

Anamorelin HCl.

Placebo.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. 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.

The full record lists 10 inclusion and 36 exclusion criteria; among the exclusions: other forms of lung cancer; women who are pregnant or breast-feeding; recent active excessive alcohol or illicit drug use current use of marijuana or history of marijuana use over the previous 6 months.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this Anamorelin (non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Anamorelin (non-peptide) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Anamorelin (non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2012-06 with completion listed for 2016-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Total Body Potassium (time frame: day 84).

It also tracked 11 secondary outcomes, for example Lean Mass Measured by Densitometry, Muscle Strength as Measured by Grip Strength, Body Weight, Quality of Life, Appetite and Resting Energy Expenditure.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Anamorelin (non-peptide) in 10 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Anamorelin (non-peptide) compound page, all human trials.