Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients: a Randomized Double-blind Placebo- Controlled Trial

Conditions
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Metastatic NSCLC

Intervention / Treatment
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* Dietary Supplement: Chinese herbs formula: Shu Yu Wan
* Other: Placebo capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese herbs formula: Shu Yu Wan<br>Participants will receive Shu Yu Wan capsules, to take 3 times daily for 6 weeks. | Dietary Supplement: Chinese herbs formula: Shu Yu Wan<br>* Shu Yu Wan Formula is a combination of 23 natural chinese herbs.This formula may be used to relieve chemotherapeutic side effects or cancer-related symptoms.<br>|
| Placebo Comparator: Placebo<br>Participants will receive capsules to take 3 times daily for 6 weeks. | Other: Placebo capsules<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Well-Being Scores at Baseline and 6 Weeks | The primary objective is to compare the change in patient reported Physical Well-Being (PWB) subscale of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. The Physical well-being (PWB) subscale has 7 questions with the range of the score from 0 to 4 each. The range of the total score is 0 to 28. The higher the score the better the physical well-being. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue scores at Baseline and 6 weeks | The secondary objective is to compare change in Fatigue subscale on the Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) questionnaire. Symptoms and health status will be assessed using the Functional Assessment of Cancer Therapy-lung (FACT-L), and Functional Assessment for Chronic Illness Therapy - Fatigue (FACIT-F). The FACT-L is a 36-item self-report questionnaire that evaluates quality of life in lung cancer patients. Twenty-nine items measure physical, social, emotional and functional well-being; The final 7 items constitute the Lung Cancer Symptom Scale (LCSS). The FACIT-F Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Metastatic, Symptom management,