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Enrolling by Invitation

NCT Number: NCT07422727

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

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.

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Key information

Conditions

Hot Flashes Cancer Hormonal Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SligoUniversity HospitaL

Sligo, F91H684, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cooling Gel Mats

Other

Participant will use the Cooling gel mats for 8 weeks at night

Other names: Silentnight© cooling gel pads

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Sligo General Hospital

Other

Registry information

Official study title

COOLVAS: Exploring the Feasibility and Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Treatment: A Pilot Study

Acronym: COOLVAS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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