A study for evaluating efficacy of cystine and theanine against peripheral neuropathy of oxaliplatin as a supportive treatment
Phase 2
- Conditions
- Peripheral neuropathy
- Registration Number
- JPRN-UMIN000020456
- Lead Sponsor
- Sendai City Medical Center, Sendai Open Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1.Active infection. 2.Poorly controlled hypertension. 3.Poorly controlled diabetes. 4.Clinically important cardiac disease. 5.Severe pulmonary disease (e.g. interstitial pneumonia , fibrosis, severe emphysema). 6.HIstory of clinically important psychopathic disorder or central nervous system damage. 7.Continuous systemic administration (iv or po) of steroid. 8.Pregnancy, breast-feeding, possible pregnancy and willing to be pregnant. 9.Participation for other studies. 10.Impossible of oral ingestion. 11.Judged ineligible by the principal investigator or sub-investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Suppressive effect of cystine and theanine on occurrence of peripheral neuropathy during receiving mFOLFOX6 therapy (Max. 6 months)
- Secondary Outcome Measures
Name Time Method State of occurrence of other adverse events of grade 2 or more. Total amount of administered oxaliplatin