Efficacy of Ginseng for Patients on Regorafenib

Exclusion Criteria

• •Subject should not be receiving any agent for fatigue including steroids, megace or opioids. NOTE: Subjects who have a contrast-induced allergy are allowed to receive steroids for their scans.
• •Radiotherapy within 2 weeks prior to study registration. Subjects must have recovered from all therapy-related toxicities.
• •Prior treatment with regorafenib.
• •Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
• •Congestive heart failure \> New York Heart Association (NYHA) class 2: unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before study registration; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted); uncontrolled hypertension (systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management).
• •Evidence or history of bleeding diathesis or coagulopathy.
• •Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration.
• •Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months of study registration.
• •Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 3 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (Non-invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)\].
• •Subjects with pheochromocytoma.
• •Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
• •Ongoing infection \> Grade 2 NCI-CTCAE v4.0.
• •Metastatic brain or meningeal tumors (symptomatic or asymptomatic).
• •Major surgical procedure or significant traumatic injury, as defined by the site investigator, within 28 days before study registration.
• •Renal failure requiring hemo- or peritoneal dialysis
• •Dehydration Grade \> 2 NCI CTCAE v4 within 7 days prior to registration.
• •Subjects with seizure disorder currently requiring medication.
• •Persistent proteinuria ≥ Grade 3 NCI CTCAE v4.0 as defined as \> 3.5 g/24 hours, measured by urine protein: creatinine ratio on a random urine sample.
• •Interstitial lung disease with ongoing signs and symptoms at the time of study registration.
• •Pleural effusion or ascites that causes respiratory compromise (≥ NCI CTCAE version 4.0 Grade 2 dyspnea).
• •History of organ allograft (including corneal transplant).
• •Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
• •Any malabsorption condition which, in the opinion of the treating physician, will affect the absorption of any of the agents used in this study.
• •Women who are pregnant or breast-feeding.
• •Any condition, which, in the site investigator's opinion, makes the subject unsuitable for trial participation.
• •Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
• •Treatment with any investigational agent within 28 days prior to registration.