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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese herbs formula: Shu Yu Wan | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese herbs formula: Shu Yu Wan | Dietary Supplement | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Jagoe, MD | Lady Davis Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Brojge Lung Cancer Center, Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
Publication in peer-reviewed journal
2019-08-20
1. Kasymjanova G, Tran AT, Cohen V, Pepe C, Sakr L, Small D, Agulnik JS, Jagoe RT: The use of a standardized Chinese herbal formula in patients with advanced lung cancer: a feasibility study. Journal of integrative medicine 2018, 16(6):390-395.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chinese Herbs Formula | A single-arm, prospective study design was chosen to test the feasibility and acceptability of using the selected Chinese herbs (CH) formula in patients with stage 4 non-small cell lung cancer (NSCLC). All participants will be offered the choice of taking the CH formula in capsules or sachets in addition to standard of care. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chinese Herbs Formula: Shu Yu Wan | 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. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for six-weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the time of enrollment treated as a continues variable |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Using CH for Full-scale Future Research | Number of participants consented over the total number of approached for the study. | Posted | Number | participants | 1 year |
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6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A Single Arm, Prospective Study | A single-arm, prospective study design was chosen to test the feasibility and acceptability of using the selected CH formula in patients with stage 4 NSCLC at our center. Patients with stage 4 NSCLC were eligible if they had Eastern Cooperative Oncology Group performance status of 0-2 and had not used CHs. In addition, to ensure that no CH-related side effects were misattributed to chemotherapy, only patients who had completed at least one cycle of their current standard chemotherapy and were clinically stable were eligible. Patients who were not on treatment were also eligible if there was no plan to recommence the treatment within the next 6 weeks. To safeguard those who were perceived to be potentially at increased risk of side effects from CHs, patients with active brain metastases, abnormal liver function or those taking tyrosine kinase inhibitors, immunosuppressive drugs, anticonvulsant and anticoagulant medications were excluded. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Intermittent |
This is a small study in a single centre leading to small number of subjects Caveat: further randomized controlled study needed to confirm the safety and benefit of of CH formula.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Goulnar Kasymjanova | Jewish General Hospita; | 514-340-8222 | 24312 | gkasymja@jgh.mcgill.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 13, 2015 | Apr 14, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2015 | Apr 14, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2015 | Apr 14, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is a feasibility study designed to see if the main study can be done.
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|
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| 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 |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Body mass index measured at the baseline and categorized as: Low <19.5 kg/m2 Normal 19.6-24.5 kg/m2 High >24.6 kg/m2 | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction
| Number | participants |
|
| Smoking status | Smokers had a history of consuming at least 5 cigarettes a day in the last 2 years; Ex-smokers are those who quit smoking 2 or more years ago; Non-smoker are those who never smoke a cigarette during the life time. Fo purpose of this study participants categorized as ex/never smokers versus smokers | Number | participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
|
| Secondary | 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 | P value (calculated) =0.03 | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
| Secondary | 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) | Number of adverse events reported between baseline and 6 weeks | Posted | Number | reported adverse events | Baseline and 6 weeks |
|
|
|
| Secondary | 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. | P value calculated | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 weeks |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 11 |
| 15 |
| constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Loss of appetite | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Infections | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Dermatitis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Emotional well-being |
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| Functional well-being |
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| Lung cancer scale |
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| Trial outcome index |
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| Title | Measurements |
|---|---|
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| Related to CH fomula |
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| Pain |
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| Strength |
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| Appetite |
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| Nausea |
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| Vomiting |
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| Constipation |
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| Drowsiness |
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| Tiredness |
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| Shortness of breath |
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| Depression |
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| Anxiety |
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| Distress |
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