Cancer, Hormonal, Hot Flashes, Sleep
Conditions
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.
Interventions
OTHERCooling Gel Mats
Participant will use the Cooling gel mats for 8 weeks at night
Sponsors
Sligo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 8 in Weekly Hot Flash Score as Recorded in the Three-Category Daily Hot Flash Diary | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Mean Daily Cooling Pad Usage and Participant Satisfaction Score Over 8 Weeks | 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. |
| Sleep quality | 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. |
| QoL | 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 |
Countries
Ireland
Contacts
PRINCIPAL_INVESTIGATORBreege Farrelly
Sligo General Hospital
Outcome results
None listed