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Completed

NCT Number: NCT03000322

Cooling Vest in Men With Hot Flashes

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.

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Key information

Conditions

Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology Center Research Institute

Englewood, New Jersey, 07631, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cooling vest

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.

Primary outcomes

  1. change in number of daily hot flashes

    Time frame: 4 weeks

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

  2. change in the intensity of daily hot flashes

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

Englewood Hospital and Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 22, 2016
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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