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

Launched by SUTTER HEALTH · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called Shengbai Oral Formula to see if it can help cancer patients who are undergoing chemotherapy. Specifically, the study wants to find out if this formula can reduce feelings of tiredness, manage pain, and improve low white blood cell counts (known as neutropenia) in patients who are on their third cycle of chemotherapy.

To be eligible for this trial, participants should be between 18 and 80 years old and have been diagnosed with cancer that is either newly identified or has returned after being in remission for at least five years. They must be scheduled to receive at least three rounds of chemotherapy, and it’s important that they have a life expectancy of more than three months. Participants can expect regular check-ins and evaluations throughout the study to monitor their health and response to the treatment. It's also important to note that certain health conditions may exclude individuals from participating, and anyone currently in another clinical trial won't be able to join this one.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18-80 years of age
• • 2. A cancer diagnosis and scheduled to undergo at least three rounds of chemotherapy for curative or palliative intent
• • 3. Chemotherapy is given at a minimum of every 2 weeks
• • 4. At least 30 days past radiation therapy
• • 5. Nonpregnant and use of method of contraception per the treating clinician standard of care
• • 6. Life expectancy \> 3 months
• • 7. Stable on all herbal or complementary therapeutics for the past 30 days and agree to not include new complementary therapeutics until after study completion
• • 8. Baseline ECOG ≤ 2
• • 9. 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:
• • 1. Abnormal ALT/AST: \> 2.5 to 3 times normal range
• • 2. eGFR \<60
• • 3. Platelets \< 75,000
• • 4. Hb \<8.0
• • 5. ANC \<1000
• • 6. Documentation of a bone marrow transplant
• • 7. Documentation of brain metastases, diagnosis with other cancer, except skin cancer history with basal cell carcinoma, squamous carcinoma
• • 8. Documentation of current seizure disorder
• • 9. Documentation of new cardiac arrhythmias and myocardial infarction
• • 10. Any active bacterial or viral infection, pneumonia, sepsis, active gastric ulcer, gastritis, nonhealing wound, intractable nausea or vomiting, diarrhea, bleeding disorder
• • 11. Hyperthyroidism, connective tissue disease including systemic lupus erythematous, rheumatoid arthritis
• • 12. Documentation of a current drug abuse disorder
• • 13. Current participation in other clinical trial