Hot Flashes, Prostate Cancer, Vasomotor Symptoms
Conditions
Keywords
Prostate Cancer, Hot Flashes, Vasomotor Symptoms
Brief summary
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
Detailed description
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.
Interventions
DEVICEEmbr 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.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Immediate vs. delayed device use
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a clinical or pathologic confirmed diagnosis of prostate cancer * Patients must be undergoing treatment with standard androgen deprivation therapy (i.e., GnRH agonist or antagonist) for ≥ 4 weeks. Patients must remain on ADT for the duration of the study (12 weeks); they may receive treatment with an androgen receptor pathway inhibitor (ARPI), radioligand therapy, or immunotherapy combined with ADT. * Patients must report bothersome hot flash symptoms (defined as ≥ 28 hot flashes per week, perceived to be at least moderately bothersome to the patient), during a period of at least 30 days prior to entering the study. * Age ≥18 years. * ECOG performance status ≤ 2 * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Pregnant and nursing women are excluded as prostate cancer is a disease of men. * Participants with a concurrent diagnosis, including separate malignancy, that may limit life expectancy \< 6 months. * Systemic antineoplastic therapy besides approved ARPI, radioligand therapy, and immunotherapy - enrollment in a clinical trial that is using SOC therapeutic options in these categories is allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hot Flash Related Daily Interference Scale (HFRDIS) Score | Assessed 6 weeks after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HFRDIS Score [week 12] | Assessed at 12 weeks after randomization | 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. |
| Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score | Assessed at 6 weeks and 12 weeks after randomization | 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). |
| PROMIS Sleep-Related Impairment Score | Assessed at 6 weeks and 12 weeks after randomization | 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). |
| HFRDIS Score Change from Baseline to Week 6 | Assessed at baseline and 6 weeks after randomization | 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. |
| HFRDIS Score Change from Week 6 to Week 12 | Assessed at 6 weeks and 12 weeks after randomization | 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. |
| PROMIS Sleep Disturbance Score Change from Baseline to Week 6 | Assessed at baseline and 6 weeks after randomization | 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). |
| PROMIS Sleep Disturbance Score Change from Weeek 6 to Week 12 | Assessed at 6 and 12 weeks after randomization | 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). |
| PROMIS Sleep-Related Impairment Score Change from Baseline to Week 6 | Assessed at baseline and 6 weeks after randomization | 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). |
| PROMIS Sleep-Related Impairment Score Change from Week 6 to Week 12 | Assessed at 6 and 12 weeks after randomization | 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). |
Contacts
CONTACTDaniel Sentana Lledo, MD
PRINCIPAL_INVESTIGATORDaniel Sentana Lledo, MD
Dana-Farber Cancer Institute
Outcome results
None listed