Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Therapy (COOLVAS)

February 12, 2026 updated by: Breege Farrelly, Sligo General Hospital

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Sligo
      • Sligo, Sligo, Ireland, F91H684
        • SligoUniversity HospitaL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cooling Mat
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
Other Names:
  • Silentnight© cooling gel pads

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 8weeks
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.
8weeks
Mean Daily Cooling Pad Usage and Participant Satisfaction Score Over 8 Weeks
Time Frame: 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
Time Frame: 8 Weeks

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.
8 Weeks
QoL
Time Frame: 8 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sligo General Hospital

Investigators

  • Principal Investigator: Breege Farrelly, Sligo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 7. Rada, G., Capurro, D., Pantoja, T., Corbalán, J., Moreno, G., Letelier, L.M. and Vera, C. (2022) 'Non-hormonal interventions for hot flushes in women with a history of breast cancer', Cochrane Database of Systematic Reviews, Issue 12
  • 6. Hutton, B., Hersi, M., Cheng, W., Pratt, M., Barbeau, P., Yazdi, F., Mazzarello, S., Ahmadzai, N., Skidmore, B., Morgan, S.C., Bordeleau, L., Ginex, P.K., Sadeghirad, B., Morgan, R.L., Cole, K. and Clemons, M. (2020) 'Comparing Interventions for Management of Hot Flashes in Patients With Breast and Prostate Cancer: A Systematic Review With Meta-Analyses', Oncology Nursing Forum, 47(4), pp. E86-E106.
  • 5. Guttuso, T., DiGrazio, W.J. and Reddy, S.Y. (2012) 'Review of hot flash diaries', Maturitas, 71(3), pp. 213-216.
  • 4. Gupta, A. (2018) 'Hormone Therapy-Related Hot Flashes and Their Management', JAMA Oncology, 4(4), p. 595.
  • 3. Carpenter, J.S. (2001) 'The Hot Flash Related Daily Interference Scale: A Tool for Assessing the Impact of Hot Flashes on Quality of Life Following Breast Cancer', Journal of Pain and Symptom Management, 22(6), pp. 979-989.
  • 2. Brook Hervik, J. and Stub, T. (2016) 'Adverse effects of non-hormonal pharmacological interventions in breast cancer survivors, suffering from hot flashes: A systematic review and meta-analysis', Breast Cancer Research and Treatment, 160, pp. 223-236.
  • 1. Avis, N.E., Levine, B.J. and Coeytaux, R. (2022) 'Results of a pilot study of a cooling mattress pad to reduce vasomotor symptoms and improve sleep', Menopause, 29(8), pp. 973-978.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1031SUHREC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not appropiate

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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