Stellate Ganglion Block (SGB) For Women for Breast Cancer
Condition: Hot Flushes; Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Hypotheses: The frequency and intensity of subjective and objective VMS will be significantly
      lower in women randomized to active SGB as compared to sham controls. Mood, memory,
      cognition, sleep, and quality of life will all be improved in the treatment group as compared
      to the sham-control group.

      Specific Goals and Objectives:

      Goal 1: To determine the effect of stellate ganglion blockade (SGB) for reducing subjective
      and objective VMS in women with breast cancer on tamoxifen, AIs, or SERMs Goal 2: To evaluate
      the effect of SGB on mood, memory, cognition, sleep and quality of life in women with breast
      cancer on tamoxifen, AIs, or SERMs.

      We aim to conduct a randomized, single-site, sham-control clinical trial of SGB on VMS in 30
      women with breast cancer on anti-estrogen therapy (15 per group). The primary entry criterion
      will be 28 or more moderate to very severe hot flashes per week. VMS will be measured by
      self-report on a written daily dairy over a 6-month period. Secondary outcomes include
      changes in mood, sleep, quality of life, and objective hot flashes measured by ambulatory
      monitoring (skin-conductance temperature monitoring) for 24 hours at baseline, three months
      and six months. Memory performance with neurocognitive testing will be done at baseline and 3
      months.
    

Intervention name(s): Bupivicaine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Marcaine; Sodium chloride solution
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Breast Cancer; Anti-estrogens; Hot Flushes; Tamoxifen; Aromatase inhibitors; Hot Flashes