Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cooling Gel Mats | Other | Participant will use the Cooling gel mats for 8 weeks at night |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
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
Exclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Breege Farrelly | Sligo General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SligoUniversity HospitaL | Sligo | Sligo | F91H684 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20824841 | Background | 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. | |
| 32555553 | Background | Hutton 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. |
Not provided
Not provided
not appropiate
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 16, 2025 | Jan 23, 2026 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 8 weeks |
| Sleep quality | Assess change in sleep quality using multiple tools
| 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 | 8 weeks |
| 22230663 | Background | Guttuso 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. |
| 29285546 | Background | Gupta 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. |
| 11738160 | Background | Carpenter 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. |
| 27709351 | Background | Hervik 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. |
| 35881974 | Background | Avis 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. |