Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients
Key facts
- Who runs it
- Lady Davis Institute
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- Mar 2022
- Ended
- Mar 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Chinese herbs formula: Shu Yu Wan
- Placebo capsules
- Record updated
- 28 July 2025
- Why it stopped
- unable to secure the funding despite multiple grant applications
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Patients must meet the following criteria for study entry:
- Signed informed consent
- Ability to comply with protocol
- Aged ≥18 years
- Histologically or cytologically documented metastatic NSCLC (American Joint Committee on Cancer [AJCC] staging system)
- Prior chemotherapy or radiotherapy is allowed provided the patient has recovered from any toxic effects
- Either off chemotherapy with no plans to start within the next 8 weeks OR on first or second line systemic anti-cancer treatment for NSCLC and completed at least 1 cycle of their current treatment prior to randomization. Permitted chemotherapy regimens are: standard systemic chemotherapy, targeted therapy, immunotherapy or any combinations of the three
- Karnofsky performance status of ≥60
- Life expectancy ≥ 12 weeks
- Adequate hematologic and end-organ function defined by the following laboratory results obtained within 14 days prior to the first study eligibility):; ANC 1. 3 -3.5 x\^109/L WBC counts 4.0 - 11 x\^109/L Platelet count 150 - 400 x\^109/L Hemoglobin 90 -150 g/dL Liver function tests AST ≤ 1.5 x ULN / ALT ≤ 1.5 x ULN L Serum bilirubin 3.0-17.0 x U/L INR ≤1.5 x ULN Creatinine clearance 50-120 mL/min
Who cannot take part
- Taking regular immunosuppressive medications: azathioprine (Imuran), basiliximab (Simulect), cyclosporine (Neoral, Sandimmune), daclizumab (Zenapax), muromonab-CD3 (OKT3, Orthoclone OKT3), mycophenolate (CellCept), tacrolimus (FK506, Prograf), sirolimus (Rapamune), or other immunosuppressive or anti-coagulant that metabolized by liver
- Patients who meet any of the following criteria will be excluded from the study entry:
- Active or untreated central nervous system metastases
- Uncontrolled pleural effusion
- Patients or families who do not speak English or French
- Abnormal liver function as defined above
- Taking regular anti-convulsants, Coumadin or related anti-coagulant
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The purpose of this study is to evaluate whether Chinese Herb supplements lead to a measurable improvement in symptoms commonly experienced by patients with advanced stage lung cancer and an improvement in quality of life. In our previously conducted single-arm observational study we found significant improvement in physical well-being, tiredness and drowsiness with no evidence of increased toxicity even in those on cytotoxic chemotherapy. Based on the encouraging results of this study we plan to move to a placebo-controlled study using the same Chinese Herb formula.
The 2 groups in the trial
- Chinese herbs formula: Shu Yu WanTreatment being tested
Participants will receive Shu Yu Wan capsules, to take 3 times daily for 6 weeks.
- PlaceboPlacebo, for comparison
Participants will receive capsules to take 3 times daily for 6 weeks.
Treatment: Placebo capsules
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients: a Randomized Double-blind Placebo- Controlled Trial
- Record updated
- 28 July 2025