Stellate Ganglion Block (SGB) For Women for Breast Cancer
Condition: Hot Flushes; Hot Flashes
MeSH terms: Hot Flashes
Intervention: Bupivicaine; Saline
Intervention description: A computer-generated 1:1 block randomization scheme will be used to assign participants to receive bupivacaine. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.10 mL .5% bupivicaine will be administered.; A computer-generated 1:1 block randomization scheme will be used to assign participants to receive saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card. 5 mL sterile normal saline will be administered.
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Enrollment: 37.0
Sex: Female
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Breast Cancer; Anti-estrogens; Hot Flushes; Tamoxifen; Aromatase inhibitors; Hot Flashes

Summary:

      Vasomotor symptoms (VMS) affect up to 65% of breast cancer survivors and negatively impact
      their quality of life. The investigators aim to evaluate the benefit of SGB in symptomatic
      women with breast cancer who are on anti-estrogens and are seeking relief from moderate to
      very severe VMS that are adversely affecting health and wellbeing. Women with breast cancer
      on Tamoxifen, aromatase inhibitors (AIs) or Selective Estrogen Receptor Modulators (SERMS)
      with moderate to very severe VMS will be enrolled as participants in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. aged 30 to 70 years

          2. 28 or more reported moderate-to-very severe hot flashes per week

          3. a minimum of two weeks of VMS diary recording prior to SGB

          4. current use of tamoxifen, aromatase inhibitors, or SERMs for a breast cancer
             indication for at last six months

          5. willingness to undergo fluoroscopy-guided SGB or sham treatment.

          6. Approval of healthcare provider if ≥ 21 for depression and ≥15 for anxiety on the
             Depression Anxiety and Stress Scale (DASS)

          7. Stable use of Selective Serotonin Reuptake Inhibitors (SSRIs), Selective
             Norepinephrine Reuptake Inhibitors (SNRIs) if applicable

        Exclusion Criteria:

          1. conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the
             anterior neck or cervical spine; goiter, cardiac/pulmonary compromise; acute
             illness/infection; coagulopathy or bleeding disorder; allergic
             reactions/contraindications to a local anesthetic or contrast dye);

          2. use of treatments in the past two months that can affect VMS (e.g., use of oral or
             transdermal Hormone Treatment (HT) or contraceptives, SERMS,

          3. conditions or disorders that can affect performance on cognitive tests (e.g.,
             dementia/mild cognitive impairment; stroke; traumatic brain injury; alcohol/substance
             use; inability to write, speak, or read in English, English as a second language

          4. Mini-Mental State Exam (MMSE) ≥ 28

          5. conditions that can affect sleep quality (e.g., use of sleep agents; shift work; etc.)