Metastatic NSCLC Clinical Trial
Official title:
Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients: a Randomized Double-blind Placebo- Controlled Trial
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.
Despite advances in the design and administration of anti-cancer therapies over recent years, the overall 5-year survival rate for patients with advanced stage lung cancer is 2-4%. These patients frequently suffer a range of different symptoms related to both their disease and it's treatment. As a result, there is a pressing need for research into treatments that may improve their symptoms as well as their quality of life (QOL). An increasing body of evidence suggests that complementary medicine, including carefully selected combinations of Chinese Herbs (CH), may exert beneficial effects for cancer patients in many ways. The literature suggests that CH combined with chemotherapy can improve survival rates, immediate tumor response, performance status and QOL for those with locally advanced and metastatic disease. The Shu Yu Wan (SYW) formula used in the feasibility study which demonstrated a significant improvement in symptoms and quality of life will also be employed in this interventional study. THe SYW formula consists of 23 natural Chinese herbs. This is a randomized, double-blinded, placebo-controlled, parallel-arm clinical trial with a 1:1 allocation ratio for investigating the efficacy and safety of SYW formula for the treatment of lung cancer symptoms. Patients in both groups will receive formula or placebo at a fixed dose for 6 weeks. After completion of study medication, the treatment will be unblinded and patients randomized to placebo will be offered to cross-over to SYW and will repeat visits Week 0 & Week 6. Patients will be closely monitored for safety and tolerability throughout the study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01438307 -
Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer
|
Phase 2 | |
| Recruiting |
NCT05091190 -
Immunotherapy Clearance and Phenotype of Circulating Tumor Cells in Lung and Head and Neck Cancers
|
N/A | |
| Recruiting |
NCT04170634 -
Tumoral Bone Strength Assessment by Numerical Simulation Using Quantitative CT : the MEKANOS Study
|
||
| Recruiting |
NCT05339568 -
Patient's Whole Process Follow-up Management(HOPE-1)
|
||
| Recruiting |
NCT05255302 -
De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04846452 -
Sintilimab, Anlotinib Hydrochloride and Platinum-Containing Dual-Agent Chemotherapy in NSCLC
|
Phase 2 | |
| Recruiting |
NCT05480865 -
SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation
|
Phase 1 | |
| Terminated |
NCT03417882 -
GRN-1201 With Pembrolizumab in Subjects With Metastatic PD-L1+ NSCLC
|
Phase 2 | |
| Recruiting |
NCT03589339 -
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
|
Phase 1 | |
| Suspended |
NCT05617313 -
Study of GT103 in Combination With Pembrolizumab in Refractory, Metastatic Non-Small Cell Lung Cancer
|
Phase 2 | |
| Recruiting |
NCT05403385 -
Study of Inupadenant (EOS100850) With Chemotherapy as Second Line Treatment for Nonsquamous Non-small Cell Lung Cancer
|
Phase 2 | |
| Recruiting |
NCT06159790 -
A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
|
Phase 3 |