A Study of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Cancer Patients Undergoing Chemotherapy

Description

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 Overview

Study Details

Study 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.

A Randomized, Blinded, Placebo-controlled Trial of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Patients With Cancer Undergoing Chemotherapy

A Study of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Cancer Patients Undergoing Chemotherapy

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Oakland

Sutter Health, Oakland, California, United States, 94609

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 18-80 years of age
  • 2. Recurrent cancer diagnosis after at least 5 years in remission or newly diagnosed with any cancer with a solid tumor or non-Hodgkin's Lymphoma and scheduled to undergo at least three rounds of chemotherapy for curative or palliative intent
  • 3. Chemotherapy is given at a minimum of every 3 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
  • 1. Any hormone receptor positive cancer
  • 2. Abnormal ALT/AST: \> 2.5 to 3 times normal range
  • 3. eGFR \<60
  • 4. Platelets \< 75,000
  • 5. Hb \<8.0
  • 6. ANC \<1000
  • 7. Documentation of a bone marrow transplant
  • 8. Documentation of brain metastases, diagnosis with other cancer, except skin cancer history with basal cell carcinoma, squamous carcinoma
  • 9. Documentation of current seizure disorder
  • 10. Documentation of new cardiac arrhythmias and myocardial infarction
  • 11. Standard of care does not include granulocyte-colony stimulating factor (GCSF) or Neulasta
  • 12. Any active bacterial or viral infection, pneumonia, sepsis, active gastric ulcer, gastritis, nonhealing wound, intractable nausea or vomiting, diarrhea, bleeding disorder
  • 13. Hyperthyroidism, connective tissue disease including systemic lupus erythematous, rheumatoid arthritis
  • 14. Documentation of a current drug abuse disorder
  • 15. Current participation in other clinical trial

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sutter Health,

Study Record Dates

2025-12