(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: .5% Bupivacaine Guided right sided stelate ganglion block using .5% bupivacaine (5mLs) |
Drug: .5% Bupivacaine
Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
Other Names:
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Outcome Measures
Primary Outcome Measures
- Hot flash frequency [6 months]
Frequency of weekly hot flashes by self-report hot flash diary after the SGB from baseline to 6 months after SGB
Secondary Outcome Measures
- Hot flash severity [Baseline to 6 months]
The change in hot flash severity (hot flash frequency * hot flash intensity) between baseline and 6 months after the SGB. Hot flash severity is determined using the Mean frequency = ((Fmo+Fse))/7 where Fmi, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe HF events. The Mean severity = (Fmi+2×Fmo+3×Fse)/7 where Fmi, Fmo and Fse are the weekly total number of mild, moderate or severe/very severe HF events In the case of mean severity, frequency of mild VMS is not counted at baseline.
- Hot Flash Related Daily Interference Scale (HFRDIS) score [Baseline to 6 months]
The change in Hot Flash Related Daily Interference Scale (HFRDIS) between baseline and 6 months following the intervention. Hot Flash Related Daily Interference Scale (HFRDIS)(34) is a validated measure which assesses the impact of hot flashes on overall quality of life as well as on work, social activities, leisure activities, sleep, mood, concentration, relations with others,sexuality, and enjoyment of life. A total of 10 areas are assessed with a 0-10 scale. The maximum score, demonstrating the most severe interference of HF is 100.
- PROMIS SF4a (sleep) score [Baseline to 6 months]
PROMIS SF4a (sleep) Patient Reported Outcomes Measurement Information System.One of the PROMIS measures is a 4-item questionnaire that queries sleep duration, quality, and interruption.This instrument assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The 4 items are scored 1-5 where 1 is good quality and 5 is poor quality for a total score range of 4 (good quality) to 20 (poor quality).
- Patient Global Impression of Change Score (PGIC) [1 month to 6 months after the SGB]
The PGIC assesses the participants improvement in hot flashes from the time of the SGB. This will be collected at 1, 3, and 6 month time points. The PGIC queries how much the hot flashes have improved on a scale of 1 (very much improved) to 7 (very much worse).
- Adverse events [6 months after the SGB]
Number and type of adverse events related to SGB
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men with prostate cancer (with or without metastatic disease) on ADT for at least 2 months
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Age less than 65 years
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Body Mass Index (BMI) less than 32
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Willingness to undergo image guided intervention
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Greater than 28 hot flashes per week.
Exclusion Criteria:
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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)
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Current treatment of prostate cancer with radium or chemotherapy
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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)
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Inability to write, speak, or read in English
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
Investigators
- Principal Investigator: David Walega, MD, MS, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Review.
- 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. Erratum in: BMJ Open. 2017 Jan 23;7(1):e012952corr1.
- 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.
- 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.
- Kouriefs C, Georgiou M, Ravi R. Hot flushes and prostate cancer: pathogenesis and treatment. BJU Int. 2002 Mar;89(4):379-83. Review.
- 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.
- 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.
- STU00208657