Peripheral neuropathy
Conditions
Interventions
Ingestion of supplement containing 700mg of cystine and 280mg of theanine once a day during receiving mFOLFOX6 therapy (Max. 6 months)
No ingestion of supplement instead of cystine and theanine during
Sponsors
Sendai City Medical Center, Sendai Open Hospital
Shirakawa Kosei General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.From 20 to 80 years old. 2.Performance status 0-1. 3.Able to oral ingestion. 4.Received a written informed consent by patient's self-determination.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Suppressive effect of cystine and theanine on occurrence of peripheral neuropathy during receiving mFOLFOX6 therapy (Max. 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| State of occurrence of other adverse events of grade 2 or more. Total amount of administered oxaliplatin | — |
Countries
Japan
Contacts
Public ContactTakashi Tsuchiya
Sendai City Medical Center, Sendai Open Hospital Director of the hospital, digestive surgery
Outcome results
None listed