A Feasibility Study of Chinese Herbs to Manage Cancer-related Symptoms in Patients With Advanced NSCLC

Study Overview
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Brief Summary
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The current proposal is a feasibility and acceptability study to establish the necessary groundwork for more detailed investigations into the role of CH in reducing symptoms and improving quality of life in NSCLC patients at the Jewish General Hospital (JGH). A standardized and easily administered form of CH will be used, incorporating a carefully selected combination of herbs designed to alleviate a range of common symptoms suffered by patients with advanced NSCLC.

Detailed Description
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Patients with advanced NSCLC, in addition to their very poor chances of cure or extended survival, frequently suffer a range of different symptoms related to both their disease and its treatment. As a result there is a pressing need to develop more effective anti-cancer therapies and an imperative to enhance the effects of existing treatments and alleviate symptoms more effectively. Increasing numbers of patients with cancer are using complementary medicine, including Chinese herbs (CH), and evidence is accumulating from a growing number of laboratory studies and clinical trials, that CH may exert beneficial effects for cancer patients in many ways. The current proposal is a feasibility and acceptability study to establish the necessary groundwork for more detailed investigations into the role of CH in reducing symptoms and improving quality of life in NSCLC patients at the JGH. A standardized and easily administered form of CH will be used, incorporating a carefully selected combination of herbs designed to alleviate a range of common symptoms suffered by patients with advanced NSCLC. This is a prospective, longitudinal cohort study of a 6-week clinical intervention with Chinese herbs in advanced (Stage 4) NSCLC patients All the active patients who have histologically or cytologically proven metastatic NSCLC with Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2 will be eligible to participate in the study. Quality of life will be assessed by FACT-L and Edmonton Symptom Assessment System (ESAS) questionnaires. Patient will be instructed to complete a diary each day to confirm adherence to treatment and to indicate the reason(s) that any doses were missed or treatment was stopped.

Official Title
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A Feasibility Study of Chinese Herbs (CH) to Manage Cancer-related Symptoms in Patients With Advanced Non-small-cell- Lung Cancer (NSCLC)

Conditions
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Lung Cancer

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stages 4 ECOG performance ≤ 3 Life expectancy greater than ≥ 3 months Exclusion Criteria: Receiving Tyrosine Kinase Inhibitors (TKI), (Tarceva, Iressa) Brain metastases Patients or families who do not speak English or French Abnormal liver function: Alanine aminotransaminase (ALT) > 40 U/L, Aspartate aminotransaminase (AST) > 55 U/L, Alkaline phosphatase (ALP) > 145 U/L , Bilirubin > 1.7 umol/L. Taking regular anti-convulsants, Coumadin or related anti-coagulant, lithium 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)

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: This is a feasibility study designed to see if the main study can be done.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese herbs formula: Shu Yu Wan<br>All participants will be offered the choice of taking the CH formula in capsules or sachets in addition to standard care. This study will use the Shu Yu Wan formula which comprises 23 different herbs and is based on the best evidence in the literature of use of CH in lung cancer. | Dietary Supplement: Chinese herbs formula: Shu Yu Wan<br>* The patients will be offered the choice of taking the CH formula in capsules or sachets and given instructions about recommendations to improve palatability. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for six-weeks.<br>* Other names: Chinese Yam Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Using CH for Full-scale Future Research | Number of participants consented over the total number of approached for the study. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QOL From Baseline on the 36 Items Functional Assessment of Cancer Therapy - Lung (FACT-L) at the End of the Study (Week 6) | Functional Assessment of Cancer Therapy - Lung (FACT-L) is a 36-item self-assessment questionnaire that measures QOL over the past week in patients with lung cancer. The FACT-L is made up of five subscales of question rated on a five-point Likert scale and include physical well-being (PWB, range of scores is 0-28), social/family well-being (SWB, range of scores is 0-28), emotional well-being (EWB, range of scores is 0-24), functional well-being (FWB, range of scores is 0-28), and symptoms of lung cancer scale (LCS, range of scores is 0-36). For all subscales higher score is better. A total overall score (0-144). Alternative scoring includes the Trial Outcome Index (TOI), which is the sum of the Physical, Functional, and Lung Cancer Subscales. Total score ranges from 0-92 with high score being better. The clinically meaningful changes of this measure is 6 points. Unit measure is scores on a scales. | Baseline and 6 weeks | 
| Physical Well-Being Scores at Baseline and 6 Weeks | 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. Effect size (ES) of this study based on magnitude difference of PWB scale of the FACT-L between two measures (baseline and 6 weeks). This ES will be used to calculate sample size in Phase 2 study | Baseline and 6 weeks | 
| Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC | Presence of new symptoms or changes in blood tests suggestive of new toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) | Baseline and 6 weeks | 
| Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | The Edmonton Symptom Assessment System (ESAS) is a valid and reliable assessment tool to assist in the assessment of common symptoms experienced by cancer patients including: sleep, well-being, pain, strength, appetite, nausea, vomiting, constipation, drowsiness, tiredness, shortness of breath, depression, anxiety, and distress. Each symptom is rated from 0 to 10 cm on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity. | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese herbs, lung cancer, quality of life