Recruiting

Shengbai Oral Formula

Sponsor:

Sutter Health

Code:

NCT06706752

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Shengbai Oral Formula

Inactive Placebo

Study Details

Brief 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.

Conditions

Cancer

Study ID

NCT06706752

Start date

Jan 24, 2025

Status verified date

May, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment Group

placebo comparator: Placebo Group

Interventions

Shengbai 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.

Inactive Placebo

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

Primary outcome measure

  • Brief Fatigue Inventory [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Locations

Sutter Health

Recruiting

Oakland, California, United States, 94609

Contacts

Principal Investigator:

Amy Matecki, MD, FACP, L.Ac

More Information

Sponsor

Sutter Health

Last update posted

May 15, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sutter Health on 2025-05-15.