A Study of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Cancer Patients Undergoing Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shengbai Oral Formula, Inactive Placebo.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Blinded, Placebo-controlled Trial of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Patients With Cancer Undergoing Chemotherapy
Overview
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.
Interventions
- Dietary supplement 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. - Other Inactive Placebo
Inactive placebo will be taken by mouth three times per day for 14 days.
Primary outcome measures
- Brief Fatigue Inventory [Time frame: 14 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Sutter Health — Oakland
Identifiers
NCT: NCT06706752 · 2052995