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Perioperative Use of Desmopressin (DDAVP) in Breast Cancer
Plain-language guide to NCT01606072: phase 2 interventional trial of Desmopressin, 21 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01606072
- Phase
- phase 2
- Status
- completed
- Start
- 2011-11
- Completion (planned or actual)
- 2015-02
- Participants
- 21 (actual)
- Design
- na, open label (everyone knows who gets what)
- Conditions studied
- Breast Cancer
- Results posted
- not yet
What This Study Did, in Plain Language
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
Breast cancer is one of the most commonly diagnosed malignancies among women, and its mortality is related to the capacity of tumor cells to invade and produce metastases.
It is postulated that tumor manipulation during surgery results in the release of tumor cells into circulation or the lymphatic system, and that these released cells survive due to aggregation among them or with platelets through the formation of a fibrin layer on the embolus.
Tumor cells surviving transportation through circulation will join blood vessels and invade vascular walls, forming metastases.
Who Took Part
21 actual participants took part.
It was open to women only aged from 21 years up to 60 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: A. Female subjects from 21 to 60 years of age, who have voluntarily signed the informed consent form. The following laboratory results, obtained 7 days before surgery:. Total white blood cell count ≥ 4,000/mm3. Total neutrophil count 1,500/mm3. Platelet count within normal limits.
The full record lists 12 inclusion and 1 exclusion criteria.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Desmopressin 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 2011-11 with completion listed for 2015-02.
It ran at 1 site in Argentina.
What Was Measured
It also tracked 16 secondary outcomes, for example Evidence of V2 Receptor Expression, Evidence of CTC (CIRCULATING TUMOR CELLS), Evidence of CTC (circulating tumor cells), Evidence of CTC (circulating tumor cells), Evidence of CTC (circulating tumor cells) and Evidence of CTC (circulating tumor cells).
What This Means in Plain Language
Put simply, this is a phase 2 trial of Desmopressin 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 Desmopressin compound page, all human trials.
Our Notes on the Compound
Desmopressin: A synthetic vasopressin analog (DDAVP) used for bedwetting, diabetes insipidus and some bleeding disorders.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.