Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062749) titled 'The efficacy of Shakuyaku-kanzo-to in treating peripheral neuropathy caused by chemotherapy' on Sept. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Bell Land General Hospital

Condition: Condition - Patients undergoing chemotherapy for urological tumours Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To investigate the efficacy of Shakuyaku-kanzo-to in treating peripheral neuropathy caused by chemotherapy. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Among patients undergoing chemotherapy for prostate cancer or urothelial carcinoma, those who reported pain due to numbness using the Visual Analogue Scale (VAS) were asked to take Tsumura Shakuyaku-kanzo-to, and the study will examine whether the pain caused by numbness and the numbness itself improved. Study participants will be administered Tsumura Shakuyaku-kanzo-to orally at a dose of 7.5 g per day, divided into three doses, to be taken before meals or between meals. The duration of administration will vary depending on the efficacy observed.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Patients with a VAS pain score of 1 or more due to numbness 2. Patients currently receiving chemotherapy for prostate cancer or urothelial carcinoma 3. Patients who are able to understand the contents of the informed consent document and sign the consent form of their own free will Key exclusion criteria - 1. Pregnant and breastfeeding patients 2. Patients who have expressly refused to participate 3. Patients with dementia (PS 2 or higher) 4. Patients who, due to a psychiatric disorder, are receiving regular outpatient treatment or are hospitalised in a psychiatric ward, and are deemed unable to participate in the trial 5. Any other patients deemed ineligible by the principal investigator or co-investigators Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 01 Day Date of IRB - 2026 Year 08 Month 21 Day Anticipated trial start date - 2026 Year 09 Month 01 Day Last follow-up date - 2031 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071842

Disclaimer: Curated by HT Syndication.