Cooling Vest in Men With Hot Flashes

NCT ID: NCT03000322

Last Updated: 2018-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Cooling Vest is a vest manufactured by Nanohealth, Inc. It is 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.

This study attempts to collect data on the effects of the Cooling Vest in men with hot flashes and night sweats due to the side effects of chemotherapy. Participants will use the vest for 4 weeks and questionnaires will be used to determine effect.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hot Flashes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cooling Vest

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.)

Group Type EXPERIMENTAL

Cooling Vest

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cooling Vest

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Has another existing medical condition that would prevent study compliance.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Englewood Hospital and Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eric Margolis, MD

Role: PRINCIPAL_INVESTIGATOR

Englewood Hospital and Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Urology Center Research Institute

Englewood, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-16-680

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.