Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer

NCTNCT02127073Other idAAAL5203

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Could not identify collaborator and secure additional funding after transferring the record to Montefiore Medical Center

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 8 participants (actual)
Sponsor: Montefiore Medical Center · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 30 Jan 2015
Primary completion: 18 Jan 2017
Completion: 18 Sept 2017
First posted: 30 Apr 2014 (estimated)
Last update posted: 9 Nov 2023
Conditions: Breast Cancer · Ductal Carcinoma in Situ

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2015201620172018

Ph 2
Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer
NCT02127073
30 Jan 2015 to 18 Sept 2017
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to examine the genetic material called microRNA of three types of specimens from women with breast cancer. The study also seeks to examine the effectiveness of using a new agent called oxytocin to increase the amount of nipple fluid that can be collected during surgery.

Interventions

Intranasal OxytocinDrug

Arms1

Experimental
Oxytocin
Subjects would receive 4 IU of intranasal oxytocin; one spray in each nostril, single-use.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue
Time frame · 3 years

Secondary outcomes(1)

Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid
Time frame · 3 years

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcome· 3 years

Percentage of Patients With Detection of microRNA in NAF, Serum, or Tissue

Group	Value
Oxytocin	not posted

Secondary and other outcome results(1)

Secondary outcome· 3 years

Percentage of Patients With Collection of ≥ 5 μL of Nipple Aspirate Fluid

Group	Value
Oxytocin	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
OxytocinSubjects would receive 4 IU of intranasal oxytocin; one spray in each nostril, single-use. Intranasal Oxytocin: Intranasal spray, one spray or 4 IU of oxytocin will be administered into each nostril of each patient about 15-30 minutes before NAF collection	0 / 8	0 / 8	0 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Clinical diagnosis of Ductal carcinoma in situ (DCIS) or invasive breast cancer * Candidate for breast conserving surgery or mastectomy Exclusion Criteria: * Pregnant women * Prior Breast Cancer diagnosis * Adverse reaction to Oxytocin in the past

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