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

JRCT ID: jRCTs051180101

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 16/01/2018
• Target sample size: 32
• Study type: Interventional
• Intervention(s): Administration of Keishikajutsubuto (TJ - 18) + Bushi matsu (TJ - 3023)

Outcome(s)

• Primary Outcome: dose limiting toxicity, maximum tolerated dose, recommended Dose

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Yamaue Hiroki
• Secondary ID(s): UMIN000031159