NCT03000322

Brief Summary

This study is intended to determine the efficacy of the Cooling Vest in reducing the frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy treatment for prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

10 months

First QC Date

December 15, 2016

Last Update Submit

June 13, 2018

Conditions

Hot Flashes

Outcome Measures

Primary Outcomes (2)

  • change in number of daily hot flashes

    diary will be used to record the number of daily hot flashes

    4 weeks

  • change in the intensity of daily hot flashes

    diary will be used to record the severity of daily hot flashes

    4 weeks

Study Arms (1)

Cooling Vest

EXPERIMENTAL

During the four-week Treatment Period, participants should use the Cooling Vest two times per day (once in the morning for one hour and once in the evening for one hour.)

Device: Cooling Vest

Interventions

Cooling VestDEVICE

A cool therapy device intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat. The material in the vest is safe, non-toxic, and eco-friendly.

Cooling Vest

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males, who are at least 18 years old.
  • Self-reports having at least two (2) daily hot flashes associated with prostate cancer chemotherapy-induced hot flashes and night sweats.

You may not qualify if:

  • Has another existing medical condition that would prevent study compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Center Research Institute

Englewood, New Jersey, 07631, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Margolis, MD

    Englewood Hospital and Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 22, 2016

Study Start

January 1, 2017

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

June 14, 2018

Record last verified: 2018-06

Locations

US(1)