Assessing Shengbai Oral Formula for 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

This study is testing whether Shengbai Oral Formula can help cancer patients feel less tired, in less pain, and improve their blood counts while they go through chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sutter Health (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Oakland, California)
• Trial ID: NCT06706752 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of Shengbai Oral Formula in alleviating fatigue, pain, and neutropenia in cancer patients who are undergoing their third cycle of chemotherapy. Participants will receive either the Shengbai Oral Formula or an inactive placebo to determine its impact on their symptoms. The study aims to provide insights into whether this herbal treatment can improve the quality of life for patients facing the challenges of chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with a cancer diagnosis who are scheduled for at least three rounds of chemotherapy.

Not a fit: Patients with severe blood abnormalities or those who have undergone a bone marrow transplant may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for cancer patients undergoing chemotherapy by alleviating common adverse effects.

How similar studies have performed: While the specific approach of using Shengbai Oral Formula is novel, similar studies exploring herbal treatments for chemotherapy side effects have shown promise.

Eligibility criteria

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

Where this trial is running

Oakland, California

• Sutter Health — Oakland, California, United States (Recruiting)

Study contacts

• Study coordinator: Janet Han, BSN, RN

Conditions Cancer