Prostate Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Aged 45-85 years (inclusive) male only; 2) Diagnosed with prostate cancer by Western medical standards currently undergoing endocrine therapy with accompanying hot flashes and sweating meeting the criteria for adverse reactions of hot flashes post-endocrine treatment; 3) Hot flash severity score = Grade 2 at the time of enrollment (grading based on the most pronounced sweating symptoms); 4) Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients who have taken antidepressant medications within 3 months prior to the trial; 2) Patients who have taken hypoglycemic medications within 3 months prior to the trial; 3) Other conditions causing hot flashes and sweating such as malignancies in other systems tuberculosis HIV infection bacterial infections thyroid dysfunction or those currently taking antidepressants or hypoglycemic drugs; 4) Any of the following medical histories or evidence during the screening period: • Severe cardiovascular or cerebrovascular diseases; • Active or recurrent peptic ulcers or other hemorrhagic risk conditions; • Other severe digestive system disorders; • Concurrent malignancies hematologic diseases or other severe or progressive systemic illnesses; 5) Patients with comorbid psychiatric disorders rendering them unable or unwilling to cooperate; 6) Any laboratory test result meeting the following criteria during screening: • ALT (alanine aminotransferase) or AST (aspartate aminotransferase) >1.5 times the upper limit of normal or serum creatinine (Cr) >1.2 times the upper limit of normal; • Other clinically significant laboratory abnormalities deemed ineligible by the investigator; 7) Individuals with a history of hypersensitivity or allergy to the trial drugs excipients or related components; 8) Suspected or confirmed history of alcohol or substance abuse; 9) Participation in other clinical trials within 3 months prior to enrollment; 10) Patients considered unsuitable for this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Vasomotor Symptom Severity Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily Hot Flash Score; | — |
Countries
China
Contacts
Guanganmen Hospital China Academy of Chinese Medical Sciences