(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes
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|ClinicalTrials.gov Identifier: NCT03796195|
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : March 3, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Hot Flashes||Drug: .5% Bupivacaine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study|
|Actual Study Start Date :||November 13, 2019|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||July 2024|
Experimental: .5% Bupivacaine
Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
Drug: .5% Bupivacaine
Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
Other Name: Right sided stelate ganglion block (SGB)
- Hot flash frequency [ Time Frame: 6 months ]Frequency of weekly hot flashes by self-report hot flash diary after the SGB from baseline to 6 months after SGB
- Hot flash severity [ Time Frame: Baseline to 6 months ]The change in hot flash severity (hot flash frequency * hot flash intensity) between baseline and 6 months after the 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/very severe HF events. The Mean severity = (Fmi+2×Fmo+3×Fse)/7 where Fmi, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe HF events In the case of mean severity, frequency of mild VMS is not counted at baseline.
- Hot Flash Related Daily Interference Scale (HFRDIS) score [ Time Frame: Baseline to 6 months ]The change in Hot Flash Related Daily Interference Scale (HFRDIS) between baseline and 6 months following the intervention. Hot Flash Related Daily Interference Scale (HFRDIS)(34) is a validated measure which assesses the impact of hot flashes on overall quality of life as well as on work, social activities, leisure activities, sleep, mood, concentration, relations with others,sexuality, and enjoyment of life. A total of 10 areas are assessed with a 0-10 scale. The maximum score, demonstrating the most severe interference of HF is 100.
- PROMIS SF4a (sleep) score [ Time Frame: Baseline to 6 months ]PROMIS SF4a (sleep) Patient Reported Outcomes Measurement Information System.One of the PROMIS measures is a 4-item questionnaire that queries sleep duration, quality, and interruption.This instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of 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) [ Time Frame: 1 month to 6 months after the SGB ]
The PGIC assesses the participants improvement in hot flashes from the time of the SGB. This will be collected at 1, 3, and 6 month time points.
The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse).
- Adverse events [ Time Frame: 6 months after the SGB ]Number and type of adverse events related to SGB
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796195
|Contact: David Walega, MD, MS||(312) email@example.com|
|Principal Investigator:||David Walega, MD, MS||Northwestern University|