Phase 2
Completed N=37
Stellate Ganglion Block (SGB) For Women for Breast Cancer
Hot Flushes · Hot Flashes
Source: ClinicalTrials.gov NCT02513329 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Change in Number of Night Sweats From Baseline to 6 Months After Intervention. — 5.46; 10.09 night sweats/month
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Night Sweats From Baseline to 6 Months After Intervention. |
5.46; 10.09 | — |
| PRIMARY Change in Number of Hot Flashes From Baseline to 6 Months After Intervention. [Time Frame: 6 Months After Intervention] |
34.3; 172.62 | — |
| PRIMARY Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months |
411.4; 229.8; 343.3; 594.92 | — |
| SECONDARY Survey Score Changes From Baseline to 6 Months After Intervention Using the Epidemiological Studies-Depression(CES-D) Survey. |
-.14; 1.16 | — |
| SECONDARY Changes From Baseline of Pittsburg Sleep Quality Inventory (PSQI) |
10.84; 11.92 | — |
Eligibility Criteria
Inclusion Criteria
- aged 30 to 70 years
- 28 or more reported moderate-to-very severe hot flashes per week
- a minimum of two weeks of VMS diary recording prior to SGB
- current use of tamoxifen, aromatase inhibitors, or SERMs for a breast cancer indication for at last six months
- willingness to undergo fluoroscopy-guided SGB or sham treatment.
- Approval of healthcare provider if ≥ 21 for depression and ≥15 for anxiety on the Depression Anxiety and Stress Scale (DASS)
- Stable use of Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Norepinephrine Reuptake Inhibitors (SNRIs) if applicable
Exclusion Criteria
- 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);
- 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,
- 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
- Mini-Mental State Exam (MMSE) ≥ 28
- conditions that can affect sleep quality (e.g., use of sleep agents; shift work; etc.)
Data sourced from ClinicalTrials.gov (NCT02513329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.