Phase II study of PC-SOD for chemotherapy-induced peripheral neuropathy

JRCT ID: jRCT2031210466

Registered date:03/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chemotherapy induced peripheral neuropathy (CIPN)
• Date of first enrollment: 19/01/2022
• Target sample size: 80
• Study type: Interventional
• Intervention(s): PC-SOD or placebo will be given to patients as an i.v. infusion before chemotherapy

Outcome(s)

• Primary Outcome: Incidence of CIPN

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Mizushima Tohru