Prospective Clinical Trial of Moderately Hypo-fractionated Intensity Modulated Radiation Therapy with Concurrent Administration of Daikenchuto for Prostate Cancer

UMIN ID: UMIN000053762

Registered date:23/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 2024/04/23
• Target sample size: 125
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Moderately hypo-fractionated intensity modulated radiation therapy with concurrently administration of daikenchuto

Outcome(s)

• Primary Outcome: 3-year rate of radiotherapy-related late gastrointestinal adverse events : rate of rectal bleeding due to radiation proctitis
• Secondary Outcome: 3-year and 5-year rate of radiotherapy-related late adverse events, 3-year and 5-year biological recurrence-free rate, 3-year and 5-year overall survival rate, patient-reported outcomes, and QOL evaluation using the IPSS and EPIC.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male
• Exclude criteria: 1)Patients with a history of active multiple cancers 2) Patients who are suitable for radical intensity-modulated radiotherapy for prostate cancer, but who are judged to require combination therapy with pelvic irradiation due to pelvic lymph node metastases 3)Patients who have undergone pelvic surgery or radiation therapy before obtaining consent 4)Patients who have been taking regular Chinese herbal medicines including Daikenchuto since before consent was obtained 5) Patients who are already known to be allergic to Daikenchuto and the herbal medicines contained in this drug 6) Patients who are unable to collect urine during radiotherapy due to co-morbidities such as hemodialysis 7) Patients with a history of transurethral resection of the prostate (TUR-P) due to benign prostatic hyperplasia as a comorbidity 8) Patients who are self-catheterized or have a urinary catheter continuously in place due to urinary retention or severe urinary difficulty as a comorbidity 9) Patients with a history of inflammatory bowel disease such as ulcerative colitis or Crohn's disease as a comorbidity 10)Patients with persistent lower gastrointestinal bleeding symptoms due to hemorrhoids etc. as a comorbidity 11)Patients with interstitial pneumonia as a comorbidity 12)Patients with collagen disease as a comorbidity 13) Patients with serious liver disease (AST (GOT) or ALT (GPT) 100 U or more) 14) Patients with severe renal disease (creatinine 2.0 mg/dl or more) 15)Other patients deemed unsuitable as research subjects by the research director

Related Information

• Primary Sponsor: Suita Tokushukai Hospital
• Source(s) of Monetary Support: None