Hot FlashesCOOLVASNCT07422727
Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Therapy
A study testing Cooling Gel Mats in people with Hot Flashes and Sleep, run by Sligo General Hospital at 1 site in Ireland.
Trial summary
This research study will investigate whether using a non-drug option, like a cooling mat, made of temperature-regulating materials, can help relieve the discomfort of hot flushes and/or night sweats for people receiving hormone treatment following a cancer diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hot Flashes, Sleep, Hormonal
- What is being tested?
- Cooling Gel Mats
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 10 Nov 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at time of consent
- Histologically confirmed diagnosis of breast cancer or prostate cancer
- Currently receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors, ovarian suppression therapy, androgen deprivation therapy)
- Self-reported vasomotor symptoms (e.g., hot flushes and/or night sweats) occurring at least once daily during the 2 weeks prior to screening
- Ability to understand the study procedures and provide written informed consent
Who cannot join
- Prior use of cooling mat devices specifically for management of vasomotor symptoms within the past 3 months
- Known hypersensitivity or allergy to polyvinyl chloride (PVC) or any component of the cooling mat device
- Cognitive impairment, psychiatric condition, or other medical condition that, in the opinion of the investigator, would interfere with adherence to study procedures
- Concurrent participation in another interventional clinical trial for management of vasomotor symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: COOLVAS: Exploring the Feasibility and Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Treatment: A Pilot Study
This research study will investigate whether using a non-drug option, like a cooling mat, made of temperature-regulating materials, can help relieve the discomfort of hot flushes and/or night sweats for people receiving hormone treatment following a cancer diagnosis.
Cooling mats are made from specialised material designed to keep body temperature in a comfortable range by reducing heat. Previous research has shown these materials can be helpful for managing hot flushes during menopause, and the investigators are investigating if the same benefits apply to cancer patients.
- Conditions
- Hot Flashes, Sleep, Hormonal, Cancer
- Being tested
- Cooling Gel Mats
- Medical subject headings
- Hot Flashes, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling Gel MatsOther
Also called Silentnight© cooling gel pads
Participant will use the Cooling gel mats for 8 weeks at night
| Study group | Role | What they receive |
|---|---|---|
| Cooling Mat | Experimental | This is a prospective single arm pilot study to assess the feasibility and effectiveness of cooling mats in reducing the frequency and severity of vasomotor symptoms. Receives: Other: Cooling Gel Mats |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 8 in Weekly Hot Flash Score as Recorded in the Three-Category Daily Hot Flash Diary
Reduction in Severity and Frequency of Vasomotor Symptoms Description: Participants will record daily hot flash frequency and severity (1=mild, 2=moderate, 3=severe). Weekly Hot Flash Score is calculated as frequency × severity. Higher scores indicate worse symptom burden. The outcome is the mean change in weekly Hot Flash Score from baseline to Week 8.
Measured: 8 weeks
Secondary outcomes (4)
Number of Participants With Treatment-Related Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Adverse events will be graded using NCI CTCAE v5.0 (Grades 1-5). Higher grades indicate greater severity. The outcome is the number and proportion of participants experiencing at least one treatment-related adverse event during the study period.
Measured: 8weeks
Mean Daily Cooling Pad Usage and Participant Satisfaction Score Over 8 Weeks
Participants will record daily usage in hours (0-24 hours/day) and rate satisfaction on a 5-point Likert scale (1=very dissatisfied to 5=very satisfied). Higher satisfaction scores indicate better acceptability. Outcomes include mean daily usage and mean satisfaction score over 8 weeks.
Measured: 8 weeks
Sleep quality
Assess change in sleep quality using multiple tools
- Hot Flash-Related Daily Interference Scale (HFRDIS): Measures the impact of hot flashes on daily life.
- NCI CTCAE v5 Hot Flashes: Classifies the severity of hot flashes based on their impact on daily functioning.
- PRO-CTCAE® Symptom Terms: Allows patients to report the frequency, severity, and interference of hot flashes and insomnia.
- 3-Category Daily Hot Flash Diary: Tracks the frequency and severity of hot flashes over time.
- Cooling Pad Utilization and Satisfaction: Participants will record daily usage and satisfaction with the cooling pads.
Measured: 8 Weeks
QoL
Hot Flash-Related Daily Interference Scale (HFRDIS): 10-item scale assessing interference of hot flashes with daily activities; total score 0-100 (items scored 0-10). Higher scores indicate worse interference; mean change from baseline to Week 8 analyzed.
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 - Hot Flashes: Clinician-graded severity scale, Grade 1 (mild) to Grade 5 (death). Higher grades indicate worse severity; maximum grade and proportion with Grade ≥2 analyzed.
Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®): Frequency, severity, and interference scored 0-4 per item. Higher scores indicate worse symptoms; mean change from baseline to Week 8 analyzed.
Three-Category Daily Hot Flash Diary: Daily frequency and severity (1-3); hot flash score = frequency × severity. Higher scores indicate worse symptoms; mean weekly change analyzed.
Cooling Pad Utilization and Satisfaction
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start10 Nov 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sligo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Breege Farrelly, Sligo General Hospital
- Investigators
- Breege Farrelly, Principal investigator, Sligo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422727
- Sponsor's protocol ID
- 1031SUHREC
- Acronym
- COOLVAS
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not appropiate
Publications
Rada G, Capurro D, Pantoja T, Corbalan J, Moreno G, Letelier LM, Vera C. Non-hormonal interventions for hot flushes in women with a history of breast cancer. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD004923. doi: 10.1002/14651858.CD004923.pub2.
PubMed 20824841Hutton B, Hersi M, Cheng W, Pratt M, Barbeau P, Mazzarello S, Ahmadzai N, Skidmore B, Morgan SC, Bordeleau L, Ginex PK, Sadeghirad B, Morgan RL, Cole KM, Clemons M. Comparing Interventions for Management of Hot Flashes in Patients With Breast and Prostate Cancer: A Systematic Review With Meta-Analyses. Oncol Nurs Forum. 2020 Jul 1;47(4):E86-E106. doi: 10.1188/20.ONF.E86-E106.
PubMed 32555553Guttuso T Jr, DiGrazio WJ, Reddy SY. Review of hot flash diaries. Maturitas. 2012 Mar;71(3):213-6. doi: 10.1016/j.maturitas.2011.12.003. Epub 2012 Jan 9.
PubMed 22230663Gupta A. Hormone Therapy-Related Hot Flashes and Their Management. JAMA Oncol. 2018 Apr 1;4(4):595. doi: 10.1001/jamaoncol.2017.4439. No abstract available.
PubMed 29285546Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage. 2001 Dec;22(6):979-89. doi: 10.1016/s0885-3924(01)00353-0.
PubMed 11738160Hervik JB, Stub T. Adverse effects of non-hormonal pharmacological interventions in breast cancer survivors, suffering from hot flashes: A systematic review and meta-analysis. Breast Cancer Res Treat. 2016 Nov;160(2):223-236. doi: 10.1007/s10549-016-4002-x. Epub 2016 Oct 5.
PubMed 27709351Avis NE, Levine BJ, Coeytaux R. Results of a pilot study of a cooling mattress pad to reduce vasomotor symptoms and improve sleep. Menopause. 2022 Aug 1;29(8):973-978. doi: 10.1097/GME.0000000000002010.
PubMed 35881974
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COOLVAS: Exploring the Feasibility and Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Treatment: A Pilot Study
- ClinicalTrials.gov ID
- NCT07422727
- Acronym / sponsor ID
- COOLVAS / 1031SUHREC
- Conditions
- Hot Flashes, Sleep, Hormonal, Cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sligo General HospitalUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- 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 research study will investigate whether using a non-drug option, like a cooling mat, made of temperature-regulating materials, can help relieve the discomfort of hot flushes and/or night sweats for people receiving hormone treatment following a cancer diagnosis.
Cooling mats are made from specialised material designed to keep body temperature in a comfortable range by reducing heat. Previous research has shown these materials can be helpful for managing hot flushes during menopause, and the investigators are investigating if the same benefits apply to cancer patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cooling Mat | Experimental | Other: Cooling Gel MatsThis is a prospective single arm pilot study to assess the feasibility and effectiveness of cooling mats in reducing the frequency and severity of vasomotor symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years at time of consent
- Histologically confirmed diagnosis of breast cancer or prostate cancer
- Currently receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors, ovarian suppression therapy, androgen deprivation therapy)
- Self-reported vasomotor symptoms (e.g., hot flushes and/or night sweats) occurring at least once daily during the 2 weeks prior to screening
- Ability to understand the study procedures and provide written informed consent
Key exclusion criteria (4 listed)
- Prior use of cooling mat devices specifically for management of vasomotor symptoms within the past 3 months
- Known hypersensitivity or allergy to polyvinyl chloride (PVC) or any component of the cooling mat device
- Cognitive impairment, psychiatric condition, or other medical condition that, in the opinion of the investigator, would interfere with adherence to study procedures
- Concurrent participation in another interventional clinical trial for management of vasomotor symptoms
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 Gel MatsAlso: Silentnight© cooling gel padsParticipant will use the Cooling gel mats for 8 weeks at night | Other | Cooling Mat |
Primary outcome
Change From Baseline to Week 8 in Weekly Hot Flash Score as Recorded in the Three-Category Daily Hot Flash Diary
Time frame: 8 weeks
Reduction in Severity and Frequency of Vasomotor Symptoms Description: Participants will record daily hot flash frequency and severity (1=mild, 2=moderate, 3=severe). Weekly Hot Flash Score is calculated as frequency × severity. Higher scores indicate worse symptom burden. The outcome is the mean change in weekly Hot Flash Score from baseline to Week 8.
4 secondary outcomes
Number of Participants With Treatment-Related Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Time frame: 8weeks
Mean Daily Cooling Pad Usage and Participant Satisfaction Score Over 8 Weeks
Time frame: 8 weeks
Sleep quality
Time frame: 8 Weeks
QoL
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 20824841Rada G, Capurro D, Pantoja T, Corbalan J, Moreno G, Letelier LM, Vera C. Non-hormonal interventions for hot flushes in women with a history of breast cancer. Cochrane Database Syst Rev. 2010 Sep 8;(9):CD004923. doi: 10.1002/14651858.CD004923.pub2.
- Background: PubMed 32555553Hutton B, Hersi M, Cheng W, Pratt M, Barbeau P, Mazzarello S, Ahmadzai N, Skidmore B, Morgan SC, Bordeleau L, Ginex PK, Sadeghirad B, Morgan RL, Cole KM, Clemons M. Comparing Interventions for Management of Hot Flashes in Patients With Breast and Prostate Cancer: A Systematic Review With Meta-Analyses. Oncol Nurs Forum. 2020 Jul 1;47(4):E86-E106. doi: 10.1188/20.ONF.E86-E106.
- Background: PubMed 22230663Guttuso T Jr, DiGrazio WJ, Reddy SY. Review of hot flash diaries. Maturitas. 2012 Mar;71(3):213-6. doi: 10.1016/j.maturitas.2011.12.003. Epub 2012 Jan 9.
- Background: PubMed 29285546Gupta A. Hormone Therapy-Related Hot Flashes and Their Management. JAMA Oncol. 2018 Apr 1;4(4):595. doi: 10.1001/jamaoncol.2017.4439. No abstract available.
- Background: PubMed 11738160Carpenter JS. The Hot Flash Related Daily Interference Scale: a tool for assessing the impact of hot flashes on quality of life following breast cancer. J Pain Symptom Manage. 2001 Dec;22(6):979-89. doi: 10.1016/s0885-3924(01)00353-0.
- Background: PubMed 27709351Hervik JB, Stub T. Adverse effects of non-hormonal pharmacological interventions in breast cancer survivors, suffering from hot flashes: A systematic review and meta-analysis. Breast Cancer Res Treat. 2016 Nov;160(2):223-236. doi: 10.1007/s10549-016-4002-x. Epub 2016 Oct 5.
- Background: PubMed 35881974Avis NE, Levine BJ, Coeytaux R. Results of a pilot study of a cooling mattress pad to reduce vasomotor symptoms and improve sleep. Menopause. 2022 Aug 1;29(8):973-978. doi: 10.1097/GME.0000000000002010.
- Individual participant dataSharing planned: No. not appropiate
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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.
Breege Farrelly principal investigator
Sligo General Hospital
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 Gel Mats in people with Hot Flashes and Sleep, run by Sligo General Hospital at 1 site in Ireland.
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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 20 Feb 2026. 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
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 From Baseline to Week 8 in Weekly Hot Flash Score as Recorded in the Three-Category Daily Hot Flash Diary (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07422727, which also lists 7 linked publications.
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 20 Feb 2026.