Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cooling Gel Mats.
- Who it may be relevant to
- Registry conditions: Hot Flashes, Sleep, Hormonal, Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
COOLVAS: Exploring the Feasibility and Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Treatment: A Pilot Study
Overview
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.
Interventions
- Other Cooling Gel Mats
Participant will use the Cooling gel mats for 8 weeks at night
Primary outcome measures
- 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]
Secondary outcome measures (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 [Time frame: 8weeks]
- Mean Daily Cooling Pad Usage and Participant Satisfaction Score Over 8 Weeks [Time frame: 8 weeks]
- Sleep quality [Time frame: 8 Weeks]
- QoL [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Ireland · 1 center
- SligoUniversity HospitaL — Sligo
Publications
- 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. PMID 20824841
- 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. PMID 32555553
- 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. PMID 22230663
- 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. PMID 29285546
- 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. PMID 11738160
- 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. PMID 27709351
- 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. PMID 35881974
Identifiers
NCT: NCT07422727 · 1031SUHREC