Trial Outcomes & Findings for Pilot Study of Oxytocin and microRNA Identification in NAF, Serum, and Tissue in Women With Breast Cancer (NCT NCT02127073)

NCT ID: NCT02127073

Last Updated: 2023-11-09

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

3 years

Results posted on

2023-11-09

Participant Flow

The trial officially opened to enrollment in 2015 with first patient enrolled on 1/30/2015 at Columbia University Medical Center.

Participant milestones

Participant milestones
Measure	Oxytocin Subjects 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
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxytocin n=8 Participants Subjects 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: The study was voluntarily suspended as documented in IND Annual Report (Serial Number 0007). Data was not collected/aggregated and no interim analyses were conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: The study was voluntarily suspended as documented in IND Annual Report (Serial Number 0007). Data was not collected/aggregated and no interim analyses were conducted.

Outcome measures

Outcome data not reported

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sheldon Feldman, Chief Breast Surgery and Breast Surgery Oncology

Montefiore Medical Center

Phone: 929-246-6300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place