Individual Dose-escalated Bi-daily Subcutaneously (sc) Ghrelin in Cancer Cachexia: a Phase I/II Study

What Was Tested

The trial (phase 1, phase 2) is built around Ghrelin.

Ghrelin, a 28 amino acid peptide discovered in 1999, is predominantly secreted by gastric endocrine cells and is an endogenous ligand for the growth hormone secretagogue (GHS) receptor.

It had 1 arm (groups): ghrelin (experimental).

Ghrelin, a 28 amino acid peptide discovered in 1999, is predominantly secreted by gastric endocrine cells and is an endogenous ligand for the growth hormone secretagogue (GHS) receptor. When administered peripherally it stimulates growth hormone secretion, food intake, triggers a positive energy balance, produces weight gain through a central mechanism involving hypothalamic neuropeptides and has anti-inflammatory effects.

The registry classes the interventions as drug.

Who Took Part

The registry lists 21 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: Age: Patients must be older than 18 years of age. Tumour situation: Patients with any type of advanced (defined as locally recurrent or metastatic), incurable solid tumour. No simple starvation: Patients must be able to eat, defined as no severe structural barriers in the upper gastrointestinal tract and no bowel obstruction. No late cachexia: Patient must have an expected life expectancy \> 3 months. No other trial: Patient is not or was not participating in any other clinical trial within 28 before visit 2.

The full record lists 24 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Ghrelin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-06 with completion listed for 2011-12.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To assess the effect of ghrelin on muscle strength (time frame: weekly).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Ghrelin in 21 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Ghrelin compound page, all human trials.