Clinical trial · Interventional
Embr Thermal Device for Hot Flash Management in Prostate Cancer
Feasibility of the Embr Thermal Device for Management of Hot Flashes in Men With Prostate Cancer
NCT04892914CI-TRIAL-00057571completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being conducted to evaluate if the Embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hot Flashes | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Embr thermal device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Embr thermal device
- description
- Use of the Embr thermal device
- interventionNames
- Device: Embr thermal device
Primary outcomes (2)
- measure
- Embr thermal device usage, average number of minutes per day per participant
- timeFrame
- Weeks 0 to 4
- description
- Number of minutes logged with the Embr device.
- measure
- Embr thermal device usage, average number of sessions per day per participant
- timeFrame
- Weeks 0 to 4
- description
- Number of sessions logged with the Embr device.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have received a diagnosis of prostate cancer and have received treatment with GnRH agonist or antagonist therapy or orchiectomy at least 1 month prior to enrollment. * May have received prior definitive radiation therapy or surgery (\>60 days prior to study). * Have bothersome hot flashes (occurrence ≥ 28 times per week and at least moderately bothersome). * Presence of hot flashes for \>30 days prior to study entry. * Have a working smartphone (iPhone 6 or greater; or Android 8.0 or greater). * Willing to downloading and use the Embr thermal device companion app on their phone * Willing to wear the Embr thermal device for 4 weeks, and charge and sync the device daily * In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English Exclusion Criteria: * Planned treatment with chemotherapy and/or any medical intervention that will impact hot flashes, sleep, or other daily activities of daily life during the 4-week study. * History of a known sleep disorder, other than insomnia (eg, obstructive sleep apnea, restless leg syndrome), or medical or psychiatric condition that affects sleep, or undergoing treatment for insomnia. * History of cognitive impairment or dysfunction. * Seizure history, history of recurrent falls, or known brain metastases. * Uncontrolled intercurrent illness. * Individuals with a second malignancy other than non-melanoma skin cancers. * Individuals taking psychotropic medications or illicit drugs that may alter cognition, concentration, or behavior. * Individuals taking prescription sleep medications. * Individuals who report consuming more than 7 alcoholic beverages/week and/or frequent alcohol consumption within 2 hours prior to bed.
References
Publications (0)
Data not yet available
No reference posted for this study.