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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the Shengbai Oral Formula can reduce fatigue, pain, and low white blood cell counts in cancer patients undergoing their third round of chemotherapy. Participants will receive either the formula or a placebo to evaluate the treatment's effectiveness. It suits individuals diagnosed with cancer who receive chemotherapy every two weeks and have completed at least 30 days since any radiation therapy. As an unphased trial, this study allows patients to contribute to innovative research that could enhance cancer treatment outcomes.

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.

Is there any evidence suggesting that Shengbai Oral Formula is likely to be safe for humans?

Research has shown that Shengbai Oral Formula is generally well-tolerated for managing chemotherapy side effects. One study found that patients using Shengbai experienced fewer severe cases of myelosuppression, a condition where the bone marrow slows down blood cell production. This finding suggests that the formula might help reduce some negative effects of chemotherapy.

Another study examined the safety of Shengbai and identified it as a promising option with manageable side effects for cancer patients. Although specific numbers on side effects were not detailed, the consistent research focus on safety and reducing chemotherapy side effects provides reassurance about its use.

Overall, these findings suggest that Shengbai Oral Formula could be a safe choice for managing fatigue, pain, and low white blood cell counts during chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Shengbai Oral Formula is unique because it is a natural, orally administered treatment that could offer an alternative to the typical chemotherapy and radiation therapies used for cancer, which often come with significant side effects. Unlike conventional treatments that broadly target rapidly dividing cells, Shengbai Oral Formula is believed to work by boosting the immune system specifically to fight cancer cells, potentially leading to fewer adverse effects. Researchers are excited about this approach because it represents a novel mechanism for targeting cancer, which might translate to improved patient quality of life and outcomes.

What evidence suggests that Shengbai Oral Formula might be an effective treatment for fatigue, pain, and neutropenia?

Studies have shown that the Shengbai Oral Formula can benefit people undergoing chemotherapy. Research indicates that it reduces severe myelosuppression, a condition where the bone marrow doesn't produce enough blood cells. It also lowers the risk of neutropenia, which occurs when there are too few white blood cells, making infection-fighting difficult. Additionally, Shengbai Oral Formula appears to enhance the cancer-fighting effects of chemotherapy. These findings suggest it might help manage fatigue, pain, and other side effects during cancer treatment. In this trial, participants will join either the Treatment Group receiving the Shengbai Oral Formula or the Placebo Group. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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

Life expectancy > 3 months

My chemotherapy is scheduled at least every 3 weeks.

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

Exclusion Criteria

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

ANC <1000

Documentation of a current drug abuse disorder

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8876002/

Effect of Shengbai Decoction on Chemotherapy-Induced ... Conclusions. Our results suggest that Shengbai decoction can effectively improve postoperative survival of patients with GC by alleviating chemotherapy-induced ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0753332221005576

Shengbai decoction enhances the anti-tumor efficacy of ... These results indicated that SBD was effective in supporting of cancer chemotherapy. In this study, the synergistic anti-tumor effect of SBD on hepatic ...

3. withpower.com withpower.com/trial/phase-2-neoplasms-11-2024-359de

Shengbai Oral Formula for Cancer The treatment group experienced a lower incidence of severe myelosuppression and a higher total effective rate for alleviating clinical symptoms, with no ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41202374/

Shengbai oral solution for chemotherapy-induced ... Conclusion: SBOS, in combination with platinum-based chemotherapy, demonstrated safety and significantly reduced the incidence of neutropenia.

5. sutterhealth.org sutterhealth.org/research/clinical-trials/adverse-effects-of-chemotherapy-shengbai-solution-1097505286

Adverse Effects of Chemotherapy Shengbai Solution 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06706752

A Study of Shengbai Oral Formula to Assess Safety and ... 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 ...