(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes
Condition: Prostate Cancer; Hot Flashes
MeSH terms: Prostatic Neoplasms; Hot Flashes
Intervention: .5% Bupivacaine
Intervention description: Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Stelate Ganglion Block

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.
    

Eligibility criteria:

        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