Clinical trial · Interventional
Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Therapy
COOLVAS: Exploring the Feasibility and Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Treatment: A Pilot Study
NCT07422727CI-TRIAL-00103770COOLVASenrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hormonal | — | UNRESOLVED | — |
| Hot Flashes | — | UNRESOLVED | — |
| Sleep | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cooling Gel Mats | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cooling Mat
- description
- 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.
- interventionNames
- Other: Cooling Gel Mats
Primary outcomes (1)
- measure
- Change From Baseline to Week 8 in Weekly Hot Flash Score as Recorded in the Three-Category Daily Hot Flash Diary
- timeFrame
- 8 weeks
- description
- 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.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDRada 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. PMID 20824841
- BACKGROUNDHutton 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. PMID 32555553
- BACKGROUNDGuttuso 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. PMID 22230663
- BACKGROUNDGupta 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. PMID 29285546
- BACKGROUNDCarpenter 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. PMID 11738160
- BACKGROUNDHervik 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. PMID 27709351
- BACKGROUNDAvis 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.