臨床研究等提出・公開システム

Date of registration	Dec. 03, 2021
Last modified on	Jan. 09, 2024
Trial ID	jRCT2031210466

Scientific Title	Placebo-controlled, double-blind, randomized phase II study of PC-SOD for chemotherapy-induced peripheral neuropathy
Public Title	Phase II study of PC-SOD for chemotherapy-induced peripheral neuropathy

Contact for Scientific Queries	Name	Mizushima Tohru
	Affiliation	LTT Bio-Pharma Co., Ltd.
	Address	1-2-20 Kaigan, Minato-ku Tokyo,105-0022,JAPAN
	Telephone	+81-3-5733-7391
	E-mail	t.mizushima@ltt.co.jp
Contact for Public Queries	Name	Hayato Tanji
	Affiliation	LTT Bio-Pharma Co., Ltd.
	Address	1-2-20 Kaigan, Minato-ku Tokyo,105-0022,JAPAN
	Telephone	+81-3-5733-7394
	E-mail	tanji@ltt.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 01, 2021
Actual date of first enrollment		Jan. 19, 2022
Target sample size		80
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Male or female aged 20 years or older 2. Indicated for cancer chemothrapy 3. ECOG performance status of 0 or 1 4. Adequate hematological parameters 5. Adequate renal and hepatic functions 6. Written informed consent
	Exclusion Criteria	1. Chemotherapy, immunotherapy, hormone therapy or radiotherapy for cancer within 12 months prior to enrollment 2. Any grade of sensory/motor neuropathy 3. Known hypersensitivity to PC-SOD, similar material of PC-SOD or xylitol 4. Treatment with any investigational drug within 3 months prior to enrollment 5. Pegnancy, lactation or possible pregnancy during study period
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chemotherapy induced peripheral neuropathy (CIPN)
Intervention(s)		PC-SOD or placebo will be given to patients as an i.v. infusion before chemotherapy
Primary Outcome(s)		Incidence of CIPN

Primary Sponsor	LTT Bio-Pharma Co.,Ltd.

Secondary Sponsor

Name of Certified Review Board	Nippon Medical School Hospital IRB
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
Approval Status	Approval
Date of approval	Oct. 22, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	Jan. 09, 2024	(this page)	Changes
6	Dec. 16, 2022	Detail	Changes
5	Dec. 08, 2022	Detail	Changes
4	July. 25, 2022	Detail	Changes
3	May. 17, 2022	Detail	Changes
2	Dec. 25, 2021	Detail	Changes
1	Dec. 03, 2021	Detail

List of change history