A phase II dose-escalation trial of perioperative desmopressin (1-desamino-8-d-arginine vasopressin) in breast cancer patients.

Weinberg RS, Grecco MO, Ferro GS, Seigelshifer DJ, Perroni NV, Terrier FJ, Sánchez-Luceros A, Maronna E, Sánchez-Marull R, Frahm I, Guthmann MD, Di Leo D and 10 more

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Spitzer E, Ciccia GN, Garona J, Pifano M, Torbidoni AV, Gomez DE, Ripoll GV, Gomez RE, Demarco IA, Alonso DF

SpringerPlus19 Aug 2015Cited by 32 (Europe PMC)

PMID26306290PMCIDPMC4540720DOI10.1186/s40064-015-1217-yPepBankPUB-26306290

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Summary

Desmopressin (dDAVP) is a well-known peptide analog of the antidiuretic hormone vasopressin, used to prevent excessive bleeding during surgical procedures. dDAVP increases hemostatic mediators, such as the von Willebrand factor (vWF), recently considered a key element in resistance to metastasis. Studies in mouse models and veterinary trials in dogs with locally-advanced mammary tumors demonstrated that high doses of perioperative dDAVP inhibited lymph node and early blood-borne metastasis and significantly prolonged survival. We conducted a phase II dose-escalation trial in patients with breast cancer, administering a lyophilized formulation of dDAVP by intravenous infusion in saline, 30-60 min before and 24 h after surgical resection. Primary endpoints were safety and tolerability, as well as selection of the best dose for cancer surgery. Secondary endpoints included surgical bleeding, plasma levels of vWF, and circulating tumor cells (CTCs) as measured by quantitative PCR of cytokeratin-19 transcripts. Only 2 of a total of 20 patients experienced reversible adverse events, including hyponatremia (grade 4) and hypersensitivity reaction (grade 2). Reactions were adequately managed by slowing the infusion rate. A reduced intraoperative bleeding was noted with increasing doses of dDAVP. Treatment was associated with higher vWF plasma levels and a postoperative drop in CTC counts. At the highest dose level evaluated (2 μg/kg) dDAVP appeared safe when administered in two slow infusions of 1 μg/kg, before and after surgery. Clinical trials to establish the effectiveness of adjunctive perioperative dDAVP therapy are warranted. This trial is registered on www.clinicaltrials.gov (NCT01606072).

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanNon-randomized trialSafety outcome
In breast cancer patients receiving perioperative desmopressin, two of 20 experienced reversible adverse events.
In plain wordsIn breast cancer patients receiving desmopressin around surgery, two of 20 had reversible adverse events.
Peptide
Desmopressin
Outcome
Not applicableReversible adverse events
Study
n = 20
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · intravenousAs given in this study (human).
Measurements
Patients with reversible adverse events
2 patients
total 20
Source sentences
Summary
Only 2 of a total of 20 patients experienced reversible adverse events, including hyponatremia (grade 4) and hypersensitivity reaction (grade 2).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase II dose-escalation trial in patients with breast cancer, administering a lyophilized formulation of dDAVP by intravenous infusion in saline, 30-60 min before and 24 h after surgical resection.
Show in the study text Report a problemFND-2630629001
02HumanNon-randomized trialSafety outcome
In breast cancer patients receiving perioperative desmopressin, reversible grade 4 hyponatremia occurred.
In plain wordsIn breast cancer patients receiving desmopressin around surgery, severe low blood sodium occurred and was reversible.
Peptide
Desmopressin
Outcome
Not applicableGrade 4 hyponatremia
Study
n = 20
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · intravenousAs given in this study (human).
Source sentences
Summary
Only 2 of a total of 20 patients experienced reversible adverse events, including hyponatremia (grade 4) and hypersensitivity reaction (grade 2).
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase II dose-escalation trial in patients with breast cancer, administering a lyophilized formulation of dDAVP by intravenous infusion in saline, 30-60 min before and 24 h after surgical resection.
Show in the study text Report a problemFND-2630629002
03HumanNon-randomized trialSafety outcome
In breast cancer patients receiving perioperative desmopressin, a reversible grade 2 hypersensitivity reaction occurred.
In plain wordsIn breast cancer patients receiving desmopressin around surgery, a reversible allergic-type reaction occurred.
Peptide
Desmopressin
Outcome
Not applicableGrade 2 hypersensitivity reaction
Study
n = 20
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · intravenousAs given in this study (human).
Source sentences
Summary
Only 2 of a total of 20 patients experienced reversible adverse events, including hyponatremia (grade 4) and hypersensitivity reaction (grade 2).
2 context sentences(design, population, supporting numbers)
Summary · context
Reactions were adequately managed by slowing the infusion rate.
Summary · context
We conducted a phase II dose-escalation trial in patients with breast cancer, administering a lyophilized formulation of dDAVP by intravenous infusion in saline, 30-60 min before and 24 h after surgical resection.
Show in the study text Report a problemFND-2630629003
04HumanNon-randomized trialSafety outcome
In breast cancer patients, desmopressin appeared safe at 2 μg/kg given as two slow infusions before and after surgery.
In plain wordsIn breast cancer patients, the highest desmopressin dose appeared safe when split between two slow infusions around surgery.
Peptide
Desmopressin
Outcome
Direction not reportedHighest-dose tolerability
Study
n: not reported in source
Analysis
Primary
Outcome group
Adverse events · Whole body
Studied dose
2 μg/kg total, two infusions of 1 μg/kg · intravenousAs given in this study (human).
Source sentences
Summary
At the highest dose level evaluated (2 μg/kg) dDAVP appeared safe when administered in two slow infusions of 1 μg/kg, before and after surgery.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase II dose-escalation trial in patients with breast cancer, administering a lyophilized formulation of dDAVP by intravenous infusion in saline, 30-60 min before and 24 h after surgical resection.
Show in the study text Report a problemFND-2630629007
05HumanNon-randomized trialActivity measurement
In breast cancer patients, perioperative desmopressin treatment was associated with higher plasma von Willebrand factor levels.
In plain wordsIn breast cancer patients, desmopressin treatment around surgery was linked to higher levels of a blood-clotting protein.
Peptide
Desmopressin
Outcome
IncreasePlasma von Willebrand factor
Study
n = 20
Analysis
Secondary
Outcome group
Receptor activity and mechanism · Cardiovascular
Studied dose
Dose not stated · intravenousAs given in this study (human).
Source sentences
Summary
Treatment was associated with higher vWF plasma levels and a postoperative drop in CTC counts.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase II dose-escalation trial in patients with breast cancer, administering a lyophilized formulation of dDAVP by intravenous infusion in saline, 30-60 min before and 24 h after surgical resection.
Show in the study text Report a problemFND-2630629005
06HumanNon-randomized trialActivity measurement
In breast cancer patients, perioperative desmopressin treatment was associated with a postoperative decrease in circulating tumor cell counts.
In plain wordsIn breast cancer patients, desmopressin treatment was linked to fewer circulating tumor cells after surgery.
Peptide
Desmopressin
Outcome
DecreaseCirculating tumor cell count
Study
n = 20
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
Dose not stated · intravenousAs given in this study (human).
Source sentences
Summary
Treatment was associated with higher vWF plasma levels and a postoperative drop in CTC counts.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase II dose-escalation trial in patients with breast cancer, administering a lyophilized formulation of dDAVP by intravenous infusion in saline, 30-60 min before and 24 h after surgical resection.
Show in the study text Report a problemFND-2630629006
07HumanNon-randomized trialEfficacy outcome
In breast cancer patients, intraoperative bleeding decreased with increasing perioperative desmopressin doses.
In plain wordsIn breast cancer patients, less bleeding during surgery was noted with higher desmopressin doses than with lower doses.
Peptide
Desmopressin
Outcome
DecreaseIntraoperative bleeding by dose
Study
n: not reported in source
Comparator
lower desmopressin doses
Analysis
Secondary
Outcome group
Bleeding · Cardiovascular
Studied dose
Dose not stated · intravenousAs given in this study (human).
Source sentences
Summary
A reduced intraoperative bleeding was noted with increasing doses of dDAVP.
1 context sentence(design, population, supporting numbers)
Summary · context
We conducted a phase II dose-escalation trial in patients with breast cancer, administering a lyophilized formulation of dDAVP by intravenous infusion in saline, 30-60 min before and 24 h after surgical resection.
Show in the study text Report a problemFND-2630629004

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT01606072

Perioperative Use of Desmopressin (DDAVP) in Breast Cancer

Laboratorio Elea Phoenix S.A.n = 21Nov 2011 to Jul 2015

Breast Cancer

Trial page ClinicalTrials.govUpdated 28 Aug 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

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