Back to resultsCooling Vest in Men With Hot Flashes
Primary Purpose
Hot Flashes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cooling Vest
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes
Eligibility Criteria
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.
Sites / Locations
- Urology Center Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cooling Vest
Arm Description
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.)
Outcomes
Primary Outcome Measures
change in number of daily hot flashes
diary will be used to record the number of daily hot flashes
change in the intensity of daily hot flashes
diary will be used to record the severity of daily hot flashes
Secondary Outcome Measures
Full Information
NCT ID
NCT03000322
First Posted
December 15, 2016
Last Updated
June 13, 2018
Sponsor
Englewood Hospital and Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03000322
Brief Title
Cooling Vest in Men With Hot Flashes
Official Title
Investigation of a Cooling Vest in Men With Chemotherapy-Induced Hot Flashes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Englewood Hospital and Medical Center
4. Oversight
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cooling Vest
Arm Type
Experimental
Arm Description
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.)
Intervention Type
Device
Intervention Name(s)
Cooling Vest
Intervention Description
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 Outcome Measure Information:
Title
change in number of daily hot flashes
Description
diary will be used to record the number of daily hot flashes
Time Frame
4 weeks
Title
change in the intensity of daily hot flashes
Description
diary will be used to record the severity of daily hot flashes
Time Frame
4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Margolis, MD
Organizational Affiliation
Englewood Hospital and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology Center Research Institute
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cooling Vest in Men With Hot Flashes
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