Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT02331394
Status:
COMPLETED
Last Update Posted:
2020-06-23
First Post:
2015-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Feasibility Study of Chinese Herbs to Manage Cancer-related Symptoms in Patients With Advanced NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gkasymja@jgh.mcgill.ca', 'phone': '514-340-8222', 'title': 'Goulnar Kasymjanova', 'phoneExt': '24312', 'organization': 'Jewish General Hospita;'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'description': 'not different', 'eventGroups': [{'id': 'EG000', 'title': 'A Single Arm, Prospective Study', 'description': '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.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 11, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Intermittent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Using CH for Full-scale Future Research', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Arm, Prospective Study', 'description': 'Participants received CH formula in 1 sachet or 4 capsules 3 times a day for 6 weeks'}], 'classes': [{'title': 'enrolled', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'refused', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'already taking some herbal supplement', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Number of participants consented over the total number of approached for the study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '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)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'The Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher scores is considered better.'}, {'id': 'OG001', 'title': '6 Weeks', 'description': 'Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher score is considered better.'}], 'classes': [{'title': 'Physical well-being', 'categories': [{'measurements': [{'value': '20.6', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Social well-being', 'categories': [{'measurements': [{'value': '20.4', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Emotional well-being', 'categories': [{'measurements': [{'value': '15.8', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Functional well-being', 'categories': [{'measurements': [{'value': '15.9', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Lung cancer scale', 'categories': [{'measurements': [{'value': '17.5', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Trial outcome index', 'categories': [{'measurements': [{'value': '90.2', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '93.9', 'spread': '13.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'groupDescription': 'Comparisons of repeated measures were made using paired sample t test, which compared subjects data at 2 different times: baseline and end of the study. A P value of 0.05 was considered statistically significant', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The equivalence assumes that the true mean difference between the paired samples is zero. Under this model, all observable differences are explained by random variation.Equality margins are:\n\nUpper Equivalence Margin=1.5 Lower Equivalence Margin=-1.5'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Physical Well-Being Scores at Baseline and 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Physical Well-Being (PWB) of the Functional Assessment of Cancer Therapy - Lung (FACT-L), range of the score 0-28, with 0 being best and 28 being worse'}, {'id': 'OG001', 'title': '6 Weeks', 'description': 'Physical Well-Being (PWB) of the Functional Assessment of Cancer Therapy - Lung (FACT-L), range of the score 0-28, with 0 being best and 28 being worse'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'P value (calculated) =0.03'}, {'type': 'SECONDARY', 'title': 'Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'A Single Arm, Prospective Study', 'description': '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.'}], 'classes': [{'title': 'Total number of reported adverse events (AE)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Grade 1 AEs', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2 AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Related to CH fomula', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Presence of new symptoms or changes in blood tests suggestive of new toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)', 'unitOfMeasure': 'reported adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of adverse events reported between baseline and 6 weeks'}, {'type': 'SECONDARY', 'title': 'Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Edmonton Symptom Assessment System'}, {'id': 'OG001', 'title': '6 Weeks', 'description': 'Edmonton Symptom Assessment System'}], 'classes': [{'title': 'Sleep', 'categories': [{'measurements': [{'value': '3.0', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Well-being', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Strength', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Appetite', 'categories': [{'measurements': [{'value': '3.1', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '1.7', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Drowsiness', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Tiredness', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Shortness of breath', 'categories': [{'measurements': [{'value': '3.1', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '21', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Anxiety', 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Distress', 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pared t-test was used to evaluate the significance of the change in scores'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'P value calculated'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chinese Herbs Formula', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'In the absence of prior data to guide formal power calculations, a sample size of 15 was chosen.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '14 patients, 1 dropped out', 'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Chinese Herbs Formula: Shu Yu Wan', 'description': '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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'spread': '8.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age at the time of enrollment treated as a continues variable', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'title': 'Low (<19.5)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Normal (19.6-24.5)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'High (>24.5)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Body mass index measured at the baseline and categorized as:\n\nLow \\<19.5 kg/m2 Normal 19.6-24.5 kg/m2 High \\>24.6 kg/m2', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'title': 'ECOG PS 0-1', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'ECOG PS 2-3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\n2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours\n3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours', 'unitOfMeasure': 'participants'}, {'title': 'Smoking status', 'classes': [{'title': 'Ex/never smoker', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Smoker', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': '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', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-13', 'size': 1167496, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-14T15:53', 'hasProtocol': True}, {'date': '2015-11-15', 'size': 34494, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-14T15:54', 'hasProtocol': False}, {'date': '2015-11-13', 'size': 358141, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-04-14T15:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a feasibility study designed to see if the main study can be done.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2015-01-03', 'resultsFirstSubmitDate': '2019-08-14', 'studyFirstSubmitQcDate': '2015-01-03', 'lastUpdatePostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-11', 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Using CH for Full-scale Future Research', 'timeFrame': '1 year', 'description': 'Number of participants consented over the total number of approached for the study.'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': 'Baseline and 6 weeks', 'description': '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.'}, {'measure': 'Physical Well-Being Scores at Baseline and 6 Weeks', 'timeFrame': 'Baseline and 6 weeks', 'description': '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'}, {'measure': 'Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Presence of new symptoms or changes in blood tests suggestive of new toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)'}, {'measure': 'Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS)', 'timeFrame': 'Baseline and 6 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chinese herbs', 'lung cancer', 'quality of life'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIncreasing 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.\n\nThe 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stages 4\n* ECOG performance ≤ 3\n* Life expectancy greater than ≥ 3 months\n\nExclusion Criteria:\n\n* Receiving Tyrosine Kinase Inhibitors (TKI), (Tarceva, Iressa)\n* Brain metastases\n* Patients or families who do not speak English or French\n* 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.\n* Taking regular anti-convulsants, Coumadin or related anti-coagulant, lithium\n* 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)'}, 'identificationModule': {'nctId': 'NCT02331394', 'acronym': 'CH', 'briefTitle': 'A Feasibility Study of Chinese Herbs to Manage Cancer-related Symptoms in Patients With Advanced NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Lady Davis Institute'}, 'officialTitle': 'A Feasibility Study of Chinese Herbs (CH) to Manage Cancer-related Symptoms in Patients With Advanced Non-small-cell- Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'JGH-14-150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chinese herbs formula: Shu Yu Wan', 'description': '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.', 'interventionNames': ['Dietary Supplement: Chinese herbs formula: Shu Yu Wan']}], 'interventions': [{'name': 'Chinese herbs formula: Shu Yu Wan', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Chinese Yam Pill'], 'description': '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.', 'armGroupLabels': ['Chinese herbs formula: Shu Yu Wan']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Peter Brojge Lung Cancer Center, Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Thomas Jagoe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lady Davis Institute'}]}, 'ipdSharingStatementModule': {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/30292672', 'infoTypes': ['CSR'], 'timeFrame': '2019-08-20', 'ipdSharing': 'YES', 'description': 'Publication in peer-reviewed journal', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lady Davis Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Thomas Jagoe', 'investigatorAffiliation': 'Lady Davis Institute'}}}}