N/A
Completed N=15
A Feasibility Study of Chinese Herbs to Manage Cancer-related Symptoms in Patients With Advanced NSCLC
Source: ClinicalTrials.gov NCT02331394 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Feasibility of Using CH for Full-scale Future Research — 15; 6; 5 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Using CH for Full-scale Future Research |
15; 6; 5 | — |
| 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) |
20.6; 23.3; 20.4; 20.3; 15.8; 16.1 | <0.05 sig |
| SECONDARY Physical Well-Being Scores at Baseline and 6 Weeks |
20.6; 22.3 | — |
| SECONDARY Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC |
26; 22; 4; 3 | — |
| SECONDARY Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) |
3.0; 2.9; 3.7; 2.3; 2.2; 1.7 | 0.02 sig |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02331394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.