Clinical trial NCT02331394: A Feasibility Study of Chinese Herbs to Manage Cancer-related Symptoms in Patients With Advanced NSCLC
Official title: A Feasibility Study of Chinese Herbs (CH) to Manage Cancer-related Symptoms in Patients With Advanced Non-small-cell- Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Chinese herbs
lung cancer
quality of life
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a feasibility study designed to see if the main study can be done.
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

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)

Primary outcomes:
measure: Feasibility of Using CH for Full-scale Future Research
timeFrame: 1 year
Secondary outcomes:
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
measure: Physical Well-Being Scores at Baseline and 6 Weeks
timeFrame: Baseline and 6 weeks
measure: Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC
timeFrame: Baseline and 6 weeks
measure: Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS)
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Peter Brojge Lung Cancer Center, Jewish General Hospital
state: Quebec
Study officials:
affiliation: Lady Davis Institute
name: Thomas Jagoe, MD
role: PRINCIPAL_INVESTIGATOR
References: