Clinical trial · Interventional
A Study of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Cancer Patients Undergoing Chemotherapy
A Randomized, Blinded, Placebo-controlled Trial of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Patients With Cancer Undergoing Chemotherapy
NCT06706752CI-TRIAL-00089708recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inactive Placebo | Other | — | UNRESOLVED |
| Shengbai Oral Formula | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- interventionNames
- Dietary Supplement: Shengbai Oral Formula
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- interventionNames
- Other: Inactive Placebo
Primary outcomes (1)
- measure
- Brief Fatigue Inventory
- timeFrame
- 14 days
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.