A Study of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Cancer Patients Undergoing Chemotherapy
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Cancer
In brief
The goal of this clinical trial is to assess whether Shengbai Oral Formula is a viable option for treatment of fatigue, pain, and neutropenia in patients undergoing their third cycle of chemotherapy.
Key facts
- Study ID
- NCT06706752
- Run by
- Sutter Health
- People needed
- 30
- Starts
- 2025-01-24
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-05-15
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sutter Health — Oakland, California, United States (enrolling)
Full record on ClinicalTrials.gov
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