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

Not Applicable

• Conditions: Prostate cancer

• Registration Number: JPRN-UMIN000053762
• Lead Sponsor: Suita Tokushukai Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-23
• Last Update Posted: 2 September 2024
• Study Completion: 2032-03-31

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified