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

NCT07422727 | Enrolling By Invitation

• 1 other identifier: 1031SUHREC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hot Flashes; Sleep; Hormonal; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

  8weeks

• Mean Daily Cooling Pad Usage and Participant Satisfaction Score Over 8 Weeks

  8 weeks

• Sleep quality

  8 Weeks

• QoL

  8 weeks

Study Arms (1)

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.

Other: Cooling Gel Mats

Interventions

Cooling Gel Mats OTHER

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

Also known as: Silentnight© cooling gel pads

Cooling Mat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sligo General Hospital: lead

Study Sites (1)

SligoUniversity HospitaL

Sligo, Sligo, F91H684, Ireland

Location

Related Publications (7)

• 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

  BACKGROUND

• 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.

  BACKGROUND

• 5. Guttuso, T., DiGrazio, W.J. and Reddy, S.Y. (2012) 'Review of hot flash diaries', Maturitas, 71(3), pp. 213-216.

  BACKGROUND

• 4. Gupta, A. (2018) 'Hormone Therapy-Related Hot Flashes and Their Management', JAMA Oncology, 4(4), p. 595.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Hot Flashes; Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Breege Farrelly

  Sligo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Nurse Practitioner

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 20, 2026
• Study Start: November 10, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)