Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: A placebo-controlled double blind randomized Phase II study (The GONE Study)
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000002211
- Lead Sponsor
- PO Epidemiological and Clinical Research Information Network (ECRIN)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
i.Patients who had received blood transfusion, blood products, or hematopoietic growth factors such as granulocyte-colony stimulating factor within 7 days prior to registration. ii.Patients who had used Japanese herbal (Kampo) medicines within 4 weeks before registration. iii.History of severe hypersensitivity (allergy) to any medicines. iv.Prior or current therapy for neuropathy or sensory dysfunction. v.Other active malignancies or a history of other malignancies within the past five years. vi.Uncontrolled pleural effusion or ascites. vii.Pericardial effusion. viii.A systemic inflammatory condition or serious infection. ix.Symptomatic brain metastasis. x.Significant electrocardiographic abnormality. xi.Clinically problematic cardiac disease (congestive heart failure, symptomatic coronary artery disease, uncontrolled arrhythmia, or myocardial infarction within the past 12 months). xii.Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema, etc.). xiii.Gastrointestinal bleeding that requires medication or transfusion. xiv.Diarrhea (watery) or diarrhea that interferes with daily activities for patients with a stoma. xv.Ileus or bowel obstruction. xvi.Central nervous system disorders. xvii.Senile dementia. xviii.Serious psychological disease. xix.Uncontrolled diabetes mellitus with or without diabetic neuropathy. xx.Pregnant or lactating women. xxi.Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of peripheral neurotoxicity ≥grade 2 after eight cycles of chemotherapy.
- Secondary Outcome Measures
Name Time Method the incidence of each grade of peripheral neurotoxicity after each cycle, the psychometric properties of the FACT/GOG-Ntx, time to occurrence of neurotoxicity, time to treatment failure, progression-free survival, response rate, and toxicity.