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NCT03000322 Clinical Trial

Cooling Vest in Men With Hot Flashes

Hot Flashes Clinical Trial

Official title:
Investigation of a Cooling Vest in Men With Chemotherapy-Induced Hot Flashes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03000322
Other study ID # E-16-680
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date November 2017

Study information
Verified date June 2018
Source Englewood Hospital and Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
United States Urology Center Research Institute Englewood New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Englewood Hospital and Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in number of daily hot flashes diary will be used to record the number of daily hot flashes 4 weeks
Primary change in the intensity of daily hot flashes diary will be used to record the severity of daily hot flashes 4 weeks
See also
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Active, not recruiting NCT05086705 - EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer N/A
Completed NCT05099159 - A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) Phase 3
Completed NCT01140646 - Evaluation of SAMe for Hot Flashes Phase 2