RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2025-01-24

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06706752

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Janet Han, BSN, RN

CONTACT

510-204-4405

janet.han@sutterhealth.org

Leila Murray, BSN, RN

CONTACT

510-204-1608

lilly.murray@sutterhealth.org

Study Locations (Sites)

Sutter Health

Oakland, California, 94609

United States

Collaborators and Investigators

Sponsor: Sutter Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-24

Study Completion Date2025-12

Study Record Updates

Study Start Date2025-01-24

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Cancer