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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
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.
Peter Brojge Lung Cancer Center, Jewish General Hospital
Montreal, Quebec, Canada
Feasibility of Using CH for Full-scale Future Research
Number of participants consented over the total number of approached for the study.
Time frame: 1 year
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)
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.
Time frame: Baseline and 6 weeks
Physical Well-Being Scores at Baseline and 6 Weeks
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
Time frame: Baseline and 6 weeks
Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC
Presence of new symptoms or changes in blood tests suggestive of new toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: Baseline and 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS)
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.
Time frame: Baseline and 6 weeks