Desmopressin (DDAVP) in Patients With Colorectal Cancer and Rectal Bleeding

What Was Tested

This registered phase 2 trial tested Desmopressin.

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

The registry classes the interventions as drug.

More on the Plan

Bleeding, mainly mild or moderate, has no specific treatment, and during the staging of the disease, can not be controlled.

Desmopressin, a synthetic analogue of vasopressin, is a selective agonist of the receptor V2 of vasopressin, inducing, among others, an haemostatic effect.

Interestingly, the expression of this receptor has been described in human gastrointestinal tract, including colon and rectum and in colorectal tumors.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Patients \> 18 to \< 80 years of age who have signed the informed consent form. Histological diagnosis of rectal adenocarcinoma localized, locally advanced or metastatic. Treatment indication with chemotherapy and/or radiotherapy and/or surgery according to disease stage. Acceptable organ function to be able to participate in the study, performed within 14 days prior to admission; defined by the following parameters:. Total leukocyte count greater than or equal to 4.0 x 10\^9/L.

The full record lists 15 inclusion and 15 exclusion criteria; among the exclusions: colorectal cancer without bleeding evidences; pregnancy or lactation; use of hormonal contraceptives or treatments with sexual hormones in general.

How the Study Was Run

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

Everyone knew when Desmopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2013-04 with completion listed for 2017-07.

It ran at 2 sites in Argentina (2).

Its stated primary purpose is other.

What Was Measured

It also tracked 4 secondary outcomes, for example Number of patients with grade 3 or 4 local adverse events, Number of patients with grade 3 or 4 systemic adverse events, Number of withdrawn from treatment and Number of patients with partial or complete response in clinical endpoints.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Desmopressin in 30 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 Desmopressin compound page, all human trials.