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Trial record 2 of 2 for:    EFFECT-HF

(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03796195
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : March 3, 2021
Information provided by (Responsible Party):
David Walega, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Hot Flashes Drug: .5% Bupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. Adverse events [ Time Frame: 6 months after the SGB ]
    Number and type of adverse events related to SGB

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men with prostate cancer with bothersome hot flashes.
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03796195

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Contact: David Walega, MD, MS (312) 695-4052

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United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: David Walega, MD    312-695-2500   
Contact: Valerie Torres, BS    312-695-0915   
Sponsors and Collaborators
Northwestern University
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Principal Investigator: David Walega, MD, MS Northwestern University

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Responsible Party: David Walega, Principal Investigator, Northwestern University Identifier: NCT03796195    
Other Study ID Numbers: STU00208657
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by David Walega, Northwestern University:
Stelate Ganglion Block
Additional relevant MeSH terms:
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Prostatic Neoplasms
Hot Flashes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents