Shengbai Oral Formula for Cancer

Overseen By Leila Murray, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sutter Health

Must not be taking: GCSF, Neulasta

Disqualifiers: Hormone receptor positive cancer, Abnormal ALT/AST, eGFR <60, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must be stable on any herbal or complementary treatments for the past 30 days and agree not to start new ones during the study.

What data supports the effectiveness of the treatment Shengbai Oral Formula for cancer?

Research on Shengbai decoction, a similar treatment, shows it helps improve survival rates and reduce side effects in gastric cancer patients undergoing chemotherapy by alleviating myelosuppression (a condition where bone marrow activity is decreased). ^{1 2 3 4 5}

Is Shengbai Oral Formula safe for humans?

In a study with gastric cancer patients, Shengbai decoction, a form of Shengbai Oral Formula, was used alongside chemotherapy and no adverse events related to the formula were reported. ^{2 6 7 8 9}

How does Shengbai Oral Formula differ from other cancer treatments?

Shengbai Oral Formula is unique because it is a traditional Chinese herbal medicine that helps reduce myelosuppression (a decrease in bone marrow activity leading to fewer blood cells) caused by chemotherapy, improving the completion rate of chemotherapy and survival rates in cancer patients without causing additional adverse effects. ^{1 2 4 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for cancer patients aged 18-80 undergoing their third chemotherapy cycle, who have been stable on current treatments for at least a month and are not pregnant. They should not be part of another clinical trial, have certain blood disorders, infections, or severe liver/kidney issues.

Inclusion Criteria

My chemotherapy is scheduled at least every 3 weeks.

I am not pregnant and use birth control as advised by my doctor.

Life expectancy > 3 months

Exclusion Criteria

Abnormal ALT/AST: > 2.5 to 3 times normal range

ANC <1000

I have hyperthyroidism or a connective tissue disease like lupus or rheumatoid arthritis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants undergo their third cycle of chemotherapy while receiving Shengbai Oral Formula or placebo

3 weeks

Treatment

Participants receive Shengbai Oral Formula or placebo to assess its effects on fatigue, pain, and neutropenia

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Shengbai Oral Formula

Trial Overview The study tests Shengbai Oral Formula against an inactive placebo to see if it can reduce fatigue, pain, and neutropenia in cancer patients during chemotherapy. Participants will receive either the formula or placebo alongside their regular treatment.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

Group II: Placebo Group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Sutter Health

Lead Sponsor

Trials

26

Recruited

68,900+

Findings from Research

Shuanghuang Shengbai granule effectively reverses cyclophosphamide-induced myelosuppression by promoting the proliferation of bone marrow hematopoietic stem cells, as evidenced by significant increases in white blood cell counts and specific stem cell ratios in treated mice.

The granule also inhibits the proliferation of lung cancer stem cells, suggesting its dual role in enhancing hematopoiesis while preventing tumor growth, with specific microRNAs identified as potential therapeutic targets for these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shuanghuang Shengbai granule cures myelosuppression and suppresses lung cancer progression: mechanism and therapeutic targets from the aspect of microRNAs. Wang, S., Xu, Z., Wang, L.[2019]

In a study of 115 gastric cancer patients, those who received Shengbai decoction alongside chemotherapy experienced significantly less myelosuppression, including lower rates of neutropenia, thrombocytopenia, and anemia, compared to those who received chemotherapy alone.

Patients taking Shengbai decoction also had a higher completion rate of adjuvant chemotherapy and better 3-year overall survival and recurrence-free survival rates, indicating its potential as a supportive treatment in improving outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Shengbai Decoction on Chemotherapy-Induced Myelosuppression and Survival of Gastric Cancer Patients After Radical Resection: A Retrospective Study. Yao, L., Feng, W., Tao, Y., et al.[2022]

In a study of 213 patients with oral squamous cell carcinoma, the Chinese prescription 'Shen Yang' showed a trend towards improved survival rates over 3, 5, 8, and 10 years compared to a placebo, with increases of 8.46% to 9.26%.

However, the differences in survival rates between the 'Shen Yang' group and the control group were not statistically significant, indicating that while there may be a potential benefit, further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long term follow-up results of Chinese prescription "Shen Yang" in the combined and sequential treatment of oral squamous cell carcinoma]. Lin, GC., Qiu, WL., Lu, CY., et al.[2009]

Shaunghuang Shengbai Granule (SHSBG) significantly increased leukocyte counts in tumor patients undergoing chemotherapy, with effective rates of 75% and 88.89% in treated groups compared to 54.55% and 58.33% in control groups.

SHSBG demonstrated protective effects on the bone marrow hematopoietic microenvironment in mice, suggesting it may help mitigate bone marrow suppression caused by chemotherapy in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical and experimental study on effect of shuanghuang shengbai granule on myelosuppression induced by chemotherapy and ultrastructure observation of bone marrow in mice]. Xu, ZY., Zhu, YW., Zhou, WD.[2017]

A meta-analysis of 13 randomized controlled trials involving 860 patients indicated that Shenqi Fuzheng Injection (SFI) combined with chemotherapy improves quality of life and enhances treatment efficacy in advanced gastric cancer compared to chemotherapy alone.

The combination treatment with SFI also resulted in fewer severe adverse events, such as nausea, vomiting, and myelosuppression, suggesting a potential safety benefit alongside its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shenqi Fuzheng Injection for advanced gastric cancer: a systematic review of randomized controlled trials. Li, J., Wang, JC., Ma, B., et al.[2021]

Kangai injection (KAI) significantly enhances the effectiveness of chemotherapy in advanced colorectal cancer patients, improving tumor response and quality of life as indicated by a higher Karnofsky performance status.

KAI also reduces the occurrence of adverse drug reactions such as nausea, vomiting, and leukopenia, while increasing immune function and prolonging survival time, although it does not affect renal dysfunction caused by chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kangai Injection, a Traditional Chinese Medicine, Improves Efficacy and Reduces Toxicity of Chemotherapy in Advanced Colorectal Cancer Patients: A Systematic Review and Meta-Analysis. Huang, S., Peng, W., Mao, D., et al.[2022]

In a study involving 156 mice with chemotherapy-related leukocytopenia, the combination of three oral drugs (Berbamine Hydrochloride, Qijiao Shengbai Capsule, and Leucogen) with granulocyte colony-stimulating factor (G-CSF) significantly improved white blood cell (WBC) and platelet (PLT) counts compared to the control group, indicating enhanced efficacy in treating leukopenia.

The combination treatment not only elevated WBC and PLT levels but also improved red blood cell (RBC) and hemoglobin (Hb) counts, suggesting a comprehensive benefit for blood cell production in chemotherapy-induced immune suppression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of Chemotherapy Related Leukocytopenia by Oral Administration of Multiple Leucogenic Drugs Combined with G-CSF: an Experimental Study]. Zhang, XP., Zhang, X., Yang, HJ., et al.[2018]

Shengmai San combined with Curcumae Longae Rhizoma (Jianghuang) enhances the therapeutic effects of radiation therapy on nasopharyngeal carcinoma, suggesting a potential new approach in traditional Chinese medicine for cancer treatment.

The study found that while radiation therapy reduces the diversity and total number of intestinal flora in mice, Shengmai Jianghuang San helps protect and partially restore this diversity, indicating its role as a sensitizing adjuvant in radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of Shengmai Jianghuang San on intestinal flora in nude mice with radio resistant cells of nasopharyngeal carcinoma]. Yang, JB., Zhu, DQ., Shao, M., et al.[2020]

In a study of 182 patients with digestive tract tumors, combining Shenqi Fuzheng Injection (SQFZI) with chemotherapy resulted in a significantly higher remission rate (20.2%) and stabilization rate (87.9%) compared to chemotherapy alone (15.6% and 68.9%, respectively).

SQFZI demonstrated a protective effect on the hematopoietic system, with fewer patients experiencing low white blood cell counts after treatment compared to those receiving only chemotherapy, and it improved immune cell activity without causing harm to heart, liver, or kidney functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study on Shenqi Fuzheng injection combined with chemotherapy in treating malignant tumor of digestive tract]. Xin, M., Wang, J., Zhou, C.[2016]

In a study of 330 cancer patients undergoing chemotherapy, the traditional Chinese herbal medicine Shuanghuang Shengbai Granule (SSG) significantly improved white blood cell (WBC) levels compared to the control group, indicating its efficacy in reducing myelosuppression caused by chemotherapy.

The treatment group experienced a lower incidence of severe myelosuppression and a higher total effective rate for alleviating clinical symptoms, with no significant adverse events reported, suggesting that SSG is both effective and safe for patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical observation of Shuanghuang Shengbai Granule () on prevention and treatment of myelosuppression caused by chemotherapy in cancer patients. Wang, LF., Xu, ZY., Wang, ZQ., et al.[2018]

The Shugan Jianpi Formula (SGJPF) combined with chemotherapy (gemcitabine) significantly improved survival rates and tumor inhibition in a breast cancer mouse model with depression, indicating its potential as an effective treatment strategy.

SGJPF appears to enhance immune function by reducing the apoptosis of CD8+ T cells and inhibiting myeloid-derived suppressor cell (MDSC) proliferation, which may help in regulating the immune microenvironment and combating tumor growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Shugan Jianpi Formula () on myeloid-derived suppression cells-mediated depression breast cancer mice. Lu, YT., Li, J., Qi, X., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Shuanghuang Shengbai granule cures myelosuppression and suppresses lung cancer progression: mechanism and therapeutic targets from the aspect of microRNAs. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Shengbai Decoction on Chemotherapy-Induced Myelosuppression and Survival of Gastric Cancer Patients After Radical Resection: A Retrospective Study. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Long term follow-up results of Chinese prescription "Shen Yang" in the combined and sequential treatment of oral squamous cell carcinoma]. [2009]

4. China pubmed.ncbi.nlm.nih.gov

[Clinical and experimental study on effect of shuanghuang shengbai granule on myelosuppression induced by chemotherapy and ultrastructure observation of bone marrow in mice]. [2017]

5. China pubmed.ncbi.nlm.nih.gov

Shenqi Fuzheng Injection for advanced gastric cancer: a systematic review of randomized controlled trials. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Kangai Injection, a Traditional Chinese Medicine, Improves Efficacy and Reduces Toxicity of Chemotherapy in Advanced Colorectal Cancer Patients: A Systematic Review and Meta-Analysis. [2022]

7. China pubmed.ncbi.nlm.nih.gov

[Treatment of Chemotherapy Related Leukocytopenia by Oral Administration of Multiple Leucogenic Drugs Combined with G-CSF: an Experimental Study]. [2018]

8. China pubmed.ncbi.nlm.nih.gov

[Effects of Shengmai Jianghuang San on intestinal flora in nude mice with radio resistant cells of nasopharyngeal carcinoma]. [2020]

9. China pubmed.ncbi.nlm.nih.gov

[Clinical study on Shenqi Fuzheng injection combined with chemotherapy in treating malignant tumor of digestive tract]. [2016]

10. China pubmed.ncbi.nlm.nih.gov

Clinical observation of Shuanghuang Shengbai Granule () on prevention and treatment of myelosuppression caused by chemotherapy in cancer patients. [2018]

11. China pubmed.ncbi.nlm.nih.gov

Effects of Shugan Jianpi Formula () on myeloid-derived suppression cells-mediated depression breast cancer mice. [2022]