N/A N=15 Other

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

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02331394 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcome: Primary: Feasibility of Using CH for Full-scale Future Research — 15; 6; 5 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Chinese herbs formula: Shu Yu Wan (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lady Davis Institute
Primary completion: Dec 2017

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

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.

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)

View full record on ClinicalTrials.gov →

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.