Status:
TERMINATED
(SGB) in Men Treated for Prostate Cancer Improve Hot Flashes
Lead Sponsor:
Northwestern University
Conditions:
Prostate Cancer
Hot Flashes
Eligibility:
MALE
18-65 years
Phase:
PHASE4
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,...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03796195
Start Date
November 13 2019
End Date
July 16 2021
Last Update
January 25 2023
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611