NCT03796195

Brief Summary

Androgen Deprivation Therapy (ADT) is a critical component of advanced prostate cancer treatment but causes numerous adverse effects including decreased bone mass, decreased muscle mass, gynecomastia, erectile dysfunction, loss of sexual desire, depression, disordered sleep, urinary symptoms, and hot flashes (HF). HF are unpleasant paroxysmal episodes of flushing, sweating with vasodilation of the face, neck, and chest. These episodes can last for seconds to minutes and are often associated with night sweats, anxiety, and insomnia and have negative effects on quality of life. Stellate ganglion blockade (SGB) with local anesthetic may be an effective treatment of HF in men on ADT, but has not been studied in any published clinical trials. The stellate ganglion is a neural structure in the anterior cervical spine region and is part of the sympathetic nervous system. It has been injected safely in the practice of pain management for more than 50 years in cases of post herpetic neuralgia (shingles), complex regional pain syndrome (CRPS) and other painful neuropathies as well as some types of cardiac dysrhythmias. Given the frequency and severity and interference of HF in men on ADT for prostate cancer, in addition to the negative effects HF impose on this patient population and a paucity of effective treatments, finding alternative treatments for HF in this population is needed.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_4 prostate-cancer

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_4 prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

November 13, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2021

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 25, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.7 years

First QC Date

January 3, 2019

Results QC Date

July 13, 2022

Last Update Submit

January 3, 2023

Conditions

Prostate CancerHot Flashes

Keywords

Stelate Ganglion Block

Outcome Measures

Primary Outcomes (1)

  • Hot Flash Frequency Change Baseline to 3 Months After Treatment.

    Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.

    3 months after SGB procedure

Secondary Outcomes (3)

  • Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block

    3 months after stellate ganglion block

  • PROMIS SF4a Score 4 Weeks After Stellate Ganglion Block.

    4 weeks after stellate ganglion block

  • Patient Global Impression of Change Score (PGIC)

    4 weeks after stellate ganglion block

Study Arms (1)

.5% Bupivacaine

EXPERIMENTAL

Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)

Drug: .5% Bupivacaine

Interventions

.5% BupivacaineDRUG

Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)

Also known as: Right sided stelate ganglion block (SGB)
.5% Bupivacaine

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMen with prostate cancer with bothersome hot flashes.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 months
  • Age less than 65 years
  • Body Mass Index (BMI) less than 32
  • Willingness to undergo image guided intervention
  • Greater than 28 hot flashes per week.

You may not qualify if:

  • Conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; metastatic disease in or near the cervical spine; goiter;cardiac/pulmonary compromise; sleep apnea; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye)
  • Current treatment of prostate cancer with radium or chemotherapy
  • Use of treatments in the past two months that can affect HF (e.g., testosterone or androgen supplementation) Note: SSRIs, serotonin norepinephrine uptake inhibitors, and membrane stabilizers will be allowed but must be on stable unchanged dose for at least 8 weeks)
  • Inability to write, speak, or read in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (9)

  • Gonzalez BD, Small BJ, Cases MG, Williams NL, Fishman MN, Jacobsen PB, Jim HSL. Sleep disturbance in men receiving androgen deprivation therapy for prostate cancer: The role of hot flashes and nocturia. Cancer. 2018 Feb 1;124(3):499-506. doi: 10.1002/cncr.31024. Epub 2017 Oct 26.

    PMID: 29072790BACKGROUND

  • Dosani M, Morris WJ, Tyldesley S, Pickles T. The Relationship between Hot Flashes and Testosterone Recovery after 12 Months of Androgen Suppression for Men with Localised Prostate Cancer in the ASCENDE-RT Trial. Clin Oncol (R Coll Radiol). 2017 Oct;29(10):696-701. doi: 10.1016/j.clon.2017.06.009. Epub 2017 Jul 13.

    PMID: 28712786BACKGROUND

  • Grunfeld EA, Hunter MS, Yousaf O. Men's experience of a guided self-help intervention for hot flushes associated with prostate cancer treatment. Psychol Health Med. 2017 Apr;22(4):425-433. doi: 10.1080/13548506.2016.1195504. Epub 2016 Jun 13.

    PMID: 27294289BACKGROUND

  • Kouriefs C, Georgiou M, Ravi R. Hot flushes and prostate cancer: pathogenesis and treatment. BJU Int. 2002 Mar;89(4):379-83. doi: 10.1046/j.1464-4096.2001.01761.x. No abstract available.

    PMID: 11872028BACKGROUND

  • Nishiyama T, Kanazawa S, Watanabe R, Terunuma M, Takahashi K. Influence of hot flashes on quality of life in patients with prostate cancer treated with androgen deprivation therapy. Int J Urol. 2004 Sep;11(9):735-41. doi: 10.1111/j.1442-2042.2004.00896.x.

    PMID: 15379937BACKGROUND

  • Frisk J. Managing hot flushes in men after prostate cancer--a systematic review. Maturitas. 2010 Jan;65(1):15-22. doi: 10.1016/j.maturitas.2009.10.017. Epub 2009 Dec 4.

    PMID: 19962840BACKGROUND

  • Trump DL. Commentary on "association of androgen deprivation therapy with cardiovascular death in patients with prostate cancer: a meta-analysis of randomized trials." Nguyen PL, Je Y, Schutz FA, Hoffman KE, Hu JC, Parekh A, Beckman JA, Choueiri TK, Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA: JAMA 2011;306(21):2359-66. Urol Oncol. 2012 Sep;30(5):746-7. doi: 10.1016/j.urolonc.2012.06.007. No abstract available.

    PMID: 23021559BACKGROUND

  • Gavin AT, Donnelly D, Donnelly C, Drummond FJ, Morgan E, Gormley GJ, Sharp L. Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study. BMJ Open. 2016 Dec 19;6(12):e012952. doi: 10.1136/bmjopen-2016-012952.

    PMID: 27993906BACKGROUND

  • Eziefula CU, Grunfeld EA, Hunter MS. 'You know I've joined your club... I'm the hot flush boy': a qualitative exploration of hot flushes and night sweats in men undergoing androgen deprivation therapy for prostate cancer. Psychooncology. 2013 Dec;22(12):2823-30. doi: 10.1002/pon.3355. Epub 2013 Jul 28.

    PMID: 23893467BACKGROUND

MeSH Terms

Conditions

Prostatic NeoplasmsHot Flashes

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

The study was closed early for slow enrollment.

Results Point of Contact

Title
David Walega, MD
Organization
Northwestern University
d-walega@northwestern.edu
3126952500

Study Officials

  • David Walega, MD, MS

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 8, 2019

Study Start

November 13, 2019

Primary Completion

July 16, 2021

Study Completion

July 16, 2021

Last Updated

January 25, 2023

Results First Posted

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)