Fatigue during treatment for advanced prostate cancer
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients must be diagnosed with advanced prostate cancer, use novel antiandrogenic agents or chemotherapy, and have fatigue/tiredness as side effects. Specifically, patients with a score of 1 or more in each of the FACIT-F categories of feeling tired and feeling fatigue will be targeted for participation in this study. After receiving a thorough explanation of their participation in this study, and with their full understanding and free and voluntary consent, the research subjects will receive 3 g of Ninjin'yoeito before each meal for 4 weeks as the scheduled oral treatment. Patients
Exclusion criteria
Exclusion criteria: Patients who are allergic to Kampo medicine Patients who are already taking Kampo medicine internally Other patients who are deemed inappropriate as research subjects by the principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observe the value of the score of the questionnaire FACIT-F and its change before and after (after 1 month) the administration of Ninjin'yoeito Observe changes in d-ROMs test and BAP test values before and after (after 1 month) administration of Ninjin'yoeito | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests: items measured in daily practice (WBC, RBC, Hb, Hct, Plt, GOT, GPT, T-Bil, TP, ALB, BUN, CRE, CRP, Na, K, Ca, PSA, urine sugar, urine protein, urine occult blood, urine ketone bodies, urine red blood cells, urine white blood cells) Adverse events (onset date, outcome, date of) | — |
Countries
Japan
Contacts
Kimitsu Chuo Hospital urology