Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients (CH:II)

Lady Davis Institute

Status

Withdrawn

Conditions

Metastatic NSCLC

Treatments

Dietary Supplement: Chinese herbs formula: Shu Yu Wan

Other: Placebo capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT04615884

CH:II

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.