Hot FlashesNCT03000322
Cooling Vest in Men With Hot Flashes
A study testing Cooling Vest in people with Hot Flashes, run by Englewood Hospital and Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Hot Flashes
- What is being tested?
- Cooling Vest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Has another existing medical condition that would prevent study compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Urology Center Research Institute
Englewood, New Jersey, 07631
About this study
Official title: Investigation of a Cooling Vest in Men With Chemotherapy-Induced 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.
Read the 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.
- Conditions
- Hot Flashes
- Being tested
- Cooling Vest
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: Device: Cooling Vest |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in number of daily hot flashes
diary will be used to record the number of daily hot flashes
Measured: 4 weeks
change in the intensity of daily hot flashes
diary will be used to record the severity of daily hot flashes
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Margolis, MD, Principal investigator, Englewood Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000322
- Sponsor's protocol ID
- E-16-680
- Status last verified
- Jun 2018
- First submitted
- 15 Dec 2016
- Last updated
- 14 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Cooling Vest in Men With Chemotherapy-Induced Hot Flashes
- ClinicalTrials.gov ID
- NCT03000322
- Acronym / sponsor ID
- E-16-680
- Conditions
- Hot Flashes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cooling Vest | Experimental | Device: Cooling VestDuring 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.) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Has another existing medical condition that would prevent study compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooling VestA 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. | Device | Cooling Vest |
Primary outcome
change in number of daily hot flashes
Time frame: 4 weeks
diary will be used to record the number of daily hot flashes
change in the intensity of daily hot flashes
Time frame: 4 weeks
diary will be used to record the severity of daily hot flashes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
Related trials for Hot Flashes
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Active, not recruitingPhase 3
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
Hot Flashes
Not yet recruiting
Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms
Menopause, Menopausal Vasomotor Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Margolis, MD principal investigator
Englewood Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling Vest in people with Hot Flashes, run by Englewood Hospital and Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in number of daily hot flashes (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.