Hot Flashes, Prostate Cancer
Conditions
Keywords
Stelate Ganglion Block
Brief summary
Androgen Deprivation Therapy (ADT) is a critical component of advanced prostate cancer treatment but causes numerous adverse effects including decreased bone mass, decreased muscle mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered sleep, urinary symptoms, and hot flashes (HF). HF are unpleasant paroxysmal episodes of flushing, sweating with vasodilation of the face, neck, and chest. These episodes can last for seconds to minutes and are often associated with night sweats, anxiety, and insomnia and have negative effects on quality of life. Stellate ganglion blockade (SGB) with local anesthetic may be an effective treatment of HF in men on ADT, but has not been studied in any published clinical trials. The stellate ganglion is a neural structure in the anterior cervical spine region and is part of the sympathetic nervous system. It has been injected safely in the practice of pain management for more than 50 years in cases of post herpetic neuralgia (shingles), complex regional pain syndrome (CRPS) and other painful neuropathies as well as some types of cardiac dysrhythmias. Given the frequency and severity and interference of HF in men on ADT for prostate cancer, in addition to the negative effects HF impose on this patient population and a paucity of effective treatments, finding alternative treatments for HF in this population is needed.
Interventions
DRUG.5% Bupivacaine
Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 months 2. Age less than 65 years 3. Body Mass Index (BMI) less than 32 4. Willingness to undergo image guided intervention 5. Greater than 28 hot flashes per week.
Exclusion criteria
1. Conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; metastatic disease in or near the cervical spine; goiter;cardiac/pulmonary compromise; sleep apnea; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye) 2. Current treatment of prostate cancer with radium or chemotherapy 3. Use of treatments in the past two months that can affect HF (e.g., testosterone or androgen supplementation) Note: SSRIs, serotonin norepinephrine uptake inhibitors, and membrane stabilizers will be allowed but must be on stable unchanged dose for at least 8 weeks) 4. Inability to write, speak, or read in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hot Flash Frequency Change Baseline to 3 Months After Treatment. | 3 months after SGB procedure | Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block | 3 months after stellate ganglion block | The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline. |
| PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block. | 4 weeks after stellate ganglion block | PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality). |
| Patient Global Impression of Change Score (PGIC) | 4 weeks after stellate ganglion block | The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| .5% Bupivacaine Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
.5% Bupivacaine: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs) | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study closed early | 1 |
Baseline characteristics
| Characteristic | .5% Bupivacaine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 67 years |
| Baseline Hot Flash-Related Daily Interference Scale (HFRDIS) | 48 score on a scale |
| Baseline mean daily hot flashes | 9.78 Hot flashes/day |
| Body Mass Index (kg/m^2) | 25 (kg/m^2) |
| PROMIS SF4a Sleep Score | 11 Score on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Hot Flash Frequency Change Baseline to 3 Months After Treatment.
Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.
Time frame: 3 months after SGB procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| .5% Bupivacaine | Hot Flash Frequency Change Baseline to 3 Months After Treatment. | -1.78 Hot flashes/day |
Secondary
Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block
The change in hot flash severity (hot flash frequency x hot flash intensity) between baseline and 3 months after SGB. Hot flash severity is determined using the mean frequency= ((Fmo+Fse))7 where FMi, Fmo and Fse are the weekly total number of mild, moderate or severe HF events. The mean severity= (Fmi+2x Fmo + 3 x Fse)/7 where FMI, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe hot flash events in the case of mean severity, frequency of mild vasomotor symptoms is not counted at baseline.
Time frame: 3 months after stellate ganglion block
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| .5% Bupivacaine | Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block | -55.94 Score on a scale |
Secondary
Patient Global Impression of Change Score (PGIC)
The PGIC assesses the participants improvement in hot flashes from the time of the stellate ganglion block to 4 weeks after the procedure. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse).
Time frame: 4 weeks after stellate ganglion block
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| .5% Bupivacaine | Patient Global Impression of Change Score (PGIC) | 4 Score on a scale |
Secondary
PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.
PROMIS SF4a (sleep) Patient Reportee Outcomes Measurement Information System. The PROMIS SF4a is a 4 item questionnaire that queries sleep duration, quality and interruption. This instrument accesses self reported perceptions of sleep quality, sleep depth and restoratoin associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).
Time frame: 4 weeks after stellate ganglion block
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| .5% Bupivacaine | PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block. | 8 Score on a scale |