A Study of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Cancer Patients Undergoing Chemotherapy

Inclusion criteria

• 18-80 years of age
• A cancer diagnosis and scheduled to undergo at least three rounds of chemotherapy for curative or palliative intent
• Chemotherapy is given at a minimum of every 2 weeks
• At least 30 days past radiation therapy
• Nonpregnant and use of method of contraception per the treating clinician standard of care
• Life expectancy > 3 months
• Stable on all herbal or complementary therapeutics for the past 30 days and agree to not include new complementary therapeutics until after study completion
• Baseline ECOG ≤ 2
• In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study including all scheduled evaluations and required tests

Exclusion criteria

• Abnormal ALT/AST: > 2.5 to 3 times normal range
• eGFR <60
• Platelets < 75,000
• Hb <8.0
• ANC <1000
• Documentation of a bone marrow transplant
• Documentation of brain metastases, diagnosis with other cancer, except skin cancer history with basal cell carcinoma, squamous carcinoma
• Documentation of current seizure disorder
• Documentation of new cardiac arrhythmias and myocardial infarction
• Any active bacterial or viral infection, pneumonia, sepsis, active gastric ulcer, gastritis, nonhealing wound, intractable nausea or vomiting, diarrhea, bleeding disorder
• Hyperthyroidism, connective tissue disease including systemic lupus erythematous, rheumatoid arthritis
• Documentation of a current drug abuse disorder
• Current participation in other clinical trial