Clinical trial · Interventional
(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes
Does Stellate Ganglion Blockade (SGB) in Men Treated for Prostate Cancer Improve Hot Flashes? A Pilot Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hot Flashes | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| .5% Bupivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- .5% Bupivacaine
- description
- Guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
- interventionNames
- Drug: .5% Bupivacaine
Primary outcomes (1)
- measure
- Hot Flash Frequency Change Baseline to 3 Months After Treatment.
- timeFrame
- 3 months after SGB procedure
- description
- Change in mean daily hot flashes using a self-report hot flash diary from baseline to 3 months after stellate ganglion block.
Secondary outcomes (3)
- measure
- Change in Hot Flash Severity Baseline to 3 Months After Stellate Ganglion Block
- timeFrame
- 3 months after stellate ganglion block
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 months 2. Age less than 65 years 3. Body Mass Index (BMI) less than 32 4. Willingness to undergo image guided intervention 5. Greater than 28 hot flashes per week. Exclusion Criteria: 1. 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) 2. Current treatment of prostate cancer with radium or chemotherapy 3. 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) 4. Inability to write, speak, or read in English
References
Publications (9)
- BACKGROUNDGonzalez 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 29072790
- BACKGROUNDDosani 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 28712786
- BACKGROUNDGrunfeld 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 27294289
- BACKGROUNDKouriefs 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 11872028
- BACKGROUNDNishiyama 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 15379937
- BACKGROUNDFrisk 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 19962840
- BACKGROUNDTrump 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.