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

  • STATUS
    Recruiting
  • End date
    Jul 11, 2024
  • participants needed
    20
  • sponsor
    Northwestern University
Updated on 20 February 2022
bupivacaine
body mass index
cancer
metastatic disease
depression
androgens
metastasis
antiandrogen therapy
androgen suppression
cancer treatment
flushing
insomnia
ganglion
impotence
night sweats
flashes
erectile dysfunction
gynecomastia

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.

Details
Condition Prostate Cancer, Hot Flashes
Treatment .5% Bupivacaine
Clinical Study IdentifierNCT03796195
SponsorNorthwestern University
Last Modified on20 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 months
Age less than 65 years
Body Mass Index (BMI) less than 32
Willingness to undergo image guided intervention
Greater than 28 hot flashes per week

Exclusion Criteria

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)
Current treatment of prostate cancer with radium or chemotherapy
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)
Inability to write, speak, or read in English
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