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A Randomized, Blinded, Placebo-controlled Trial of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Patients With Cancer Undergoing Chemotherapy

NCT ID: NCT06706752Sponsor: Sutter HealthLast updated: 2025-05-15

Summary

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.

Arms & interventions

  • Dietary SupplementShengbai Oral Formula

    Shengbai Oral Formula contains 11 herbs: Folium Epimedii, Fructus Lycii, Radix Astragali, Caulis Spatholobi, Radix Rubiae, Rhizoma Phragmitis, Fructus Psoraleae, Radix Angelicae Sinensis, Radix Ophiopogonis,, Radix et Rhizoma Glycyrrhizae, Radix Aconiti Lateralis Preparata (Processed). It is taken by mouth three times per day for 14 days.

  • OtherInactive Placebo

    Inactive placebo will be taken by mouth three times per day for 14 days.

Outcome measures

Primary

  • Brief Fatigue Inventory

    The Brief Fatigue Inventory (BFI) is used to assess the severity and impact of fatigue, including cancer-related fatigue. Fatigue scores on the BFI are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).

    Time frame: 14 days

Eligibility criteria

Sex: AllAge: 18 Years to 80 YearsHealthy volunteers: No
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

Study locations (1)

Sutter Health

Oakland, California, 94609

Recruiting
Janet Han, BSN, RN · Contact
Amy Matecki, MD, FACP, L.Ac · Principal Investigator
A Study of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Cancer Patients Undergoing Chemotherapy | Cancerify