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Stellate Ganglion Block (SGB) For Women for Breast Cancer

NCT02513329 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2023-06-05

Study results available
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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.

Conditions

Interventions

DRUG

Bupivicaine

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.

DRUG

Saline

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.

Sponsors & Collaborators

Principal Investigators

  • David R. Walega, MD, MSCI · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513329 on ClinicalTrials.gov