Clinical trial · Interventional
Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients
Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients: a Randomized Double-blind Placebo- Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): unable to secure the funding despite multiple grant applications
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic NSCLC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chinese herbs formula: Shu Yu Wan | Dietary Supplement | — | UNRESOLVED |
| Placebo capsules | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chinese herbs formula: Shu Yu Wan
- description
- Participants will receive Shu Yu Wan capsules, to take 3 times daily for 6 weeks.
- interventionNames
- Dietary Supplement: Chinese herbs formula: Shu Yu Wan
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants will receive capsules to take 3 times daily for 6 weeks.
- interventionNames
- Other: Placebo capsules
Primary outcomes (1)
- measure
- Physical Well-Being Scores at Baseline and 6 Weeks
- timeFrame
- Baseline and 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: 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 * 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.
References
Publications (0)
Data not yet available