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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02331394 |
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Date of registration:
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03/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Feasibility Study of Chinese Herbs to Manage Cancer-related Symptoms in Patients With Advanced NSCLC
CH |
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Scientific 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) |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02331394 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Thomas Jagoe, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lady Davis Institute |
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Key inclusion & exclusion 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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lung Cancer
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Intervention(s)
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Dietary Supplement: Chinese herbs formula: Shu Yu Wan
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Primary Outcome(s)
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Feasibility of Using CH for Full-scale Future Research
[Time Frame: 1 year]
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Secondary Outcome(s)
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Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS)
[Time Frame: Baseline and 6 weeks]
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Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC
[Time Frame: Baseline and 6 weeks]
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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)
[Time Frame: Baseline and 6 weeks]
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Physical Well-Being Scores at Baseline and 6 Weeks
[Time Frame: Baseline and 6 weeks]
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Secondary ID(s)
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JGH-14-150
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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