An interventional study of Embr Wave in Prostate Cancer, Hot Flashes and Vasomotor Symptoms, sponsored by Dana-Farber Cancer Institute. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Treatment
This is a prospective, randomized, non-pharmacologic interventional trial evaluating the effectiveness of the Embr Wave wearable thermal device in reducing hot flash burden in men with prostate cancer receiving androgen deprivation therapy (ADT). Participants will be randomized 1:1 to immediate (12 weeks) versus delayed (after 6 weeks) use of the Embr Wave device. The study aims to determine whether the device reduces vasomotor symptoms using a number of patient-reported outcomes
This is a randomized, supportive care trial in which men with prostate cancer on ADT and experiencing bothersome hot flashes will be assigned to either immediate use of the Embr Wave device for 12 weeks or delayed use (usual care for 6 weeks, then device for 6 weeks). The Embr Wave is a commercially available wearable device that provides a cooling sensation and is being tested for its ability to reduce hot flash severity and improve quality of life. Participants will be enrolled across the DF/HCC consortium and collaborative sites.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive the Embr Wave device at the start of the study and use it for 12 weeks.
Device: Embr Wave
Participants receive usual care for the first 6 weeks, then receive the Embr Wave device for the next 6 weeks.
Device: Embr Wave
A wearable thermal device that provides a cooling sensation on the wrist. The device is commercially available but not specifically approved for hot flashes in men with prostate cancer.
Hot Flash Related Daily Interference Scale (HFRDIS) Score
HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.
Time frame: Assessed 6 weeks after randomization
HFRDIS Score [week 12]
HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.
Time frame: Assessed at 12 weeks after randomization
Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
PROMIS sleep disturbance instrument is a 4-item patient-reported questionnaire that assesses perceived sleep quality, difficulty falling asleep, difficulty staying asleep, and satisfaction with sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep disturbance (poorer sleep quality).
Time frame: Assessed at 6 weeks and 12 weeks after randomization
PROMIS Sleep-Related Impairment Score
PROMIS sleep-related impairment instrument is a 4-item patient-reported questionnaire that assesses alertness, sleepiness, tiredness, and impairment in daytime functioning related to sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep-related impairment (poorer sleep).
Time frame: Assessed at 6 weeks and 12 weeks after randomization
HFRDIS Score Change from Baseline to Week 6
HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.
Time frame: Assessed at baseline and 6 weeks after randomization
HFRDIS Score Change from Week 6 to Week 12
HFRDIS is a 10-item patient-reported questionnaire that measures the degree to which hot flashes interfere with daily activities and quality of life. Each item is scored on a 0-10 numeric rating scale. Total scores range from 0 to 100, with higher scores indicating greater interference from hot flashes.
Time frame: Assessed at 6 weeks and 12 weeks after randomization
PROMIS Sleep Disturbance Score Change from Baseline to Week 6
PROMIS sleep disturbance instrument is a 4-item patient-reported questionnaire that assesses perceived sleep quality, difficulty falling asleep, difficulty staying asleep, and satisfaction with sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep disturbance (poorer sleep quality).
Time frame: Assessed at baseline and 6 weeks after randomization
PROMIS Sleep Disturbance Score Change from Weeek 6 to Week 12
PROMIS sleep disturbance instrument is a 4-item patient-reported questionnaire that assesses perceived sleep quality, difficulty falling asleep, difficulty staying asleep, and satisfaction with sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep disturbance (poorer sleep quality).
Time frame: Assessed at 6 and 12 weeks after randomization
PROMIS Sleep-Related Impairment Score Change from Baseline to Week 6
PROMIS sleep-related impairment instrument is a 4-item patient-reported questionnaire that assesses alertness, sleepiness, tiredness, and impairment in daytime functioning related to sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep-related impairment (poorer sleep).
Time frame: Assessed at baseline and 6 weeks after randomization
PROMIS Sleep-Related Impairment Score Change from Week 6 to Week 12
PROMIS sleep-related impairment instrument is a 4-item patient-reported questionnaire that assesses alertness, sleepiness, tiredness, and impairment in daytime functioning related to sleep. Each item is scored on a 1- to 5-point Likert scale. Total scores range from 4 to 20, with higher scores indicating greater sleep-related impairment (poorer sleep).
Time frame: Assessed at 6 and 12 weeks after randomization
Plan to share: Yes — The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data can be shared no earlier than 1 year following the date of publication
Access criteria: Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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