An interventional study of Cooling Gel Mats in Hot Flashes, Sleep and Hormonal, sponsored by Sligo General Hospital. Enrolling by invitation at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Sligo General Hospital · Not applicable, Interventional, and Supportive care
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.
339 studies on the registry are indexed under Hot Flashes; 56 are open to participants now.
This study's planned enrollment of 40 is below the median of 90 across 306 interventional studies indexed under Hot Flashes.
Browse Hot Flashes studies →Sligo General Hospital is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age ≥ 18 years at time of consent
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
Exclusion Criteria:
Prior use of cooling mat devices specifically for management of vasomotor symptoms within the past 3 months
Known 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Cooling Gel Mats
Participant will use the Cooling gel mats for 8 weeks at night
Also known as: Silentnight© cooling gel pads
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.
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 8 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — not appropiate
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Sligo General Hospital