Preventive effect of Bushimatsu and Keishikajutsubuto on peripheral neurotoxicity of Oxaliplatin(L-OHP) therapy: a phase II clinical study.

Phase 2

Completed

• Conditions: colorectal cancer

• Registration Number: JPRN-jRCTs051180101
• Lead Sponsor: Yamaue Hiroki

Brief Summary

There was no safety problem due to intaking of Bushimatsu. The recommended dose by DLT evaluation, which is the primary endpoint, was 1.0 g. No significant difference was observed in each item of CTCAE, Brief Pain Inventory, and PNQ in each group and each course. And more, no trend change due to dosage dose was also observed.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-07
• Study Completion: 2021-06-15
• Results First Posted: 2023-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

(1) Histologically confirmed colorectal cancer
(2) Patients with planned adjuvant chemotherapy for stage II and stage III colon cancer after curative resection, or with no prior chemotherapy for unresectable progressive recurrent colorectal cancer
(3) Patients scheduled to undergo chemotherapy including oxaliplatin
(4) Age >= 20 years
(5) ECOG performance status 0 or 1
(6) No major impediment in major organs (bone marrow, heart, lungs, liver and kidneys etc.)
(7) No hypertension and abnormality on electrocardiogram
(8) No prior chemotherapy for colorectal cancer
(9) Informed written consent before registration to this study

Exclusion Criteria

(1) Resistance to traditional Chinese medicine
(2) Pre-treatment history of oxaliplatin
(3) Concomitant active cancer
(4) Severe dysesthesia or dysesthesia with dysfunction
(5) History of severe drug hypersensitivity
(6) Clinically problematic infection
(7) Cases in whom registration in this study judged to be difficult due to clinically problematic mental / neurological diseases
(8) Patients with any of the following complications. i)poorly controlled diabetes. ii)poorly controlled hypertension. iii)interstitial pneumonia or pulmonary fibrosis. iv)intestinal palsy or intestinal obstruction. v)clinically problematic heart disease.
(9) Other patients judged unsuitable for safe inclusion in this study according to the responsible doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dose limiting toxicity, maximum tolerated dose, recommended Dose

Secondary Outcome Measures

Name	Time	Method
Change according to brief Pain Inventory (Short Form).<br>Change according to neurotoxicity Questionnaire (PNQ).<br>Peripheral motor neuropathy and peripheral sensory neuropathy change according to CTCAE v4.0.<br>Adverse event (CTCAE v4.0).<br>Electrocardiographic change.