Stellate Ganglion Block (SGB) For Women for Breast Cancer

NCT02513329 | Completed Phase 2 Results

• 1 other identifier: STU00200390
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Hot Flushes; Hot Flashes

Keywords

Breast Cancer; Anti-estrogens; Hot Flushes; Tamoxifen; Aromatase inhibitors; Hot Flashes

Outcome Measures

Primary Outcomes (3)

• Change in Number of Night Sweats From Baseline to 6 Months After Intervention.

  Change in number of mean night sweats from baseline to 6 months after intervention using a paper diary (subjective measure of frequency). Number is the change from mean baseline number of night sweats to mean 6 months after procedure (number of ns/month)

  6 months after intervention

• Change in Number of Hot Flashes From Baseline to 6 Months After Intervention. [Time Frame: 6 Months After Intervention]

  Mean change in number of hot flashes from baseline to 6 months after intervention using a paper diary (subjective measure of frequency). Number is the change from mean baseline number of hot flashes to mean 6 months after procedure (number of ns/month)

  6 months after intervention

• Intensity of Subjective Hot Flashes (HF) at Baseline and 6 Months

  Hot flashes intensity from baseline and at 6 months as reported by the subject using paper diary (subjective) measures of intensity (including mild, severe and very severe HF).Intensity scoring = Frequency\*Severity = \[(frequency of mild\*1)+(frequency of moderate\*2) + (frequency of severe\*3) + (frequency of very severe\*4)\]. Mean intensity of hot flashes at baseline and 6 months. Score on a unlimited scale of 0- infinity based on number of hot flashes. A score on the scale where 0 is good higher scores are worse.

  6 months after stellate ganglion block procedure

Secondary Outcomes (2)

• Survey Score Changes From Baseline to 6 Months After Intervention Using the Epidemiological Studies-Depression(CES-D) Survey.

  6 months following intervention

• Changes From Baseline of Pittsburg Sleep Quality Inventory (PSQI)

  6 month following intervention

Study Arms (2)

Bupivicaine

ACTIVE COMPARATOR

Stellate Ganglion Block injection with 10 mL .5 % bupivacaine.

Drug: Bupivicaine

Saline

SHAM COMPARATOR

Saline injection (.9 normal saline) 5 ml.

Drug: Saline

Interventions

Bupivicaine DRUG

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.

Also known as: Marcaine

Bupivicaine

Saline DRUG

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.

Also known as: Sodium chloride solution

Saline

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 30 to 70 years
• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Northwestern University: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Fogel J, Rubin LH, Kilic E, Walega DR, Maki PM. Physiologic vasomotor symptoms are associated with verbal memory dysfunction in breast cancer survivors. Menopause. 2020 Nov;27(11):1209-1219. doi: 10.1097/GME.0000000000001608.

  PMID: 33110036 DERIVED

MeSH Terms

Conditions

Hot Flashes; Breast Neoplasms

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Paul Fitzgerald
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312-695-1064

Study Officials

• David R. Walega, MD, MSCI

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology; Chief,Section of Pain Medicine

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 31, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: June 5, 2023
• Results First Posted: June 5, 2023

Record last verified: 2023-06

Locations

US (1)