Safety and efficacy of keishibukuryogan for hot flashes of patients with prostate cancer receiving hormonal therapy

Safety and efficacy of keishibukuryogan for hot flashes of patients with prostate cancer receiving hormonal therapy - Keishibukuryogan study for prostate cancer patients with hot flashes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000031606

Enrollment

Registered

2018-03-06

Start date

2018-03-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer patients with hot flashes receiving hormonal therapy

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Prostate cancer patients 2) Patients receiving hormonal therapy (androgen deprivation therapy) 3) Patients planning to administer keishibukuryogan for hot flashes 4) PS:0-2 and patients who can expect life prognosis for more than 1 year 5) Age: 20 years and over 6) Patients who can take oral administration of investigational drugs 7) Patients who provided written informed consent regarding study participation.

Exclusion criteria

Exclusion criteria: Patients who have any of the following conditions are excluded. 1) Patients with severe mental illness 2)Patients who have serious complications (liver, kidney disease etc.) 3) Patients who have a history of allergies or side effects in kampo 4)Castration resistant prostate cancer patients 5) Patients who took prohibited concomitant drug or keishibukuryogan within 2 weeks 6) HIV, HBV, HCV positive patients 7) Others, including patients who judged by the investigator as ineligibility for entry

Design outcomes

Primary

Measure	Time frame
Frequency , duration time and severity of hot flashes	—

Secondary

Measure	Time frame
LOH-related symptoms(AMS score) Cytokine level(IL-1beta, IL-2, IL-4, IL-6, IL-8, IL-10, INFalpha, IFNgamma, MCP-1(CCL2), MIP-1beta(CCL4),VEGF) Hormone value(testosterone, DHEA, DHT, estradiol, progesterone)	—

Countries

Japan

Contacts

Public ContactKazuyoshi Shigehara

Kanazawa University Graduate School of Medical Science Department of Integrative Cancer Therapy and Urology

kshigehara0415@yahoo.co.jp076-265-2393

Outcome results