Cancer
Conditions
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.
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.
Sponsors
Sutter Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Fatigue Inventory | 14 days | 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). |
Countries
United States
Contacts
Primary ContactJanet Han, BSN, RN
Backup ContactLeila Murray, BSN, RN
Outcome results
None listed