Lung Cancer
Conditions
Keywords
Chinese herbs, lung cancer, quality of life
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.
Interventions
DIETARY_SUPPLEMENTChinese herbs formula: Shu Yu Wan
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.
Sponsors
Lady Davis Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a feasibility study designed to see if the main study can be done.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Using CH for Full-scale Future Research | 1 year | Number of participants consented over the total number of approached for the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline and 6 weeks | 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. |
| Physical Well-Being Scores at Baseline and 6 Weeks | 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 |
| Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC | Baseline and 6 weeks | Presence of new symptoms or changes in blood tests suggestive of new toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) |
| Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Baseline and 6 weeks | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chinese Herbs Formula: Shu Yu Wan All participants will be offered the choice of taking the CH formula in capsules or sachets in addition to standard care. This study will use the Shu Yu Wan formula which comprises 23 different herbs and is based on the best evidence in the literature of use of CH in lung cancer. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for six-weeks. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease progression | 1 |
Baseline characteristics
| Characteristic | Chinese Herbs Formula: Shu Yu Wan |
|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 8.9 |
| Body Mass Index (BMI) High (>24.5) | 5 participants |
| Body Mass Index (BMI) Low (<19.5) | 2 participants |
| Body Mass Index (BMI) Normal (19.6-24.5) | 8 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG PS 0-1 | 12 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG PS 2-3 | 3 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
| Smoking status Ex/never smoker | 14 participants |
| Smoking status Smoker | 1 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 11 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A Single Arm, Prospective Study | Feasibility of Using CH for Full-scale Future Research | enrolled | 15 participants |
| A Single Arm, Prospective Study | Feasibility of Using CH for Full-scale Future Research | refused | 6 participants |
| A Single Arm, Prospective Study | Feasibility of Using CH for Full-scale Future Research | already taking some herbal supplement | 5 participants |
Secondary
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
Population: P value calculated
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Sleep | 3.0 score on a scale | Standard Deviation 3.2 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Well-being | 3.7 score on a scale | Standard Deviation 2.1 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Pain | 2.2 score on a scale | Standard Deviation 2.2 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Strength | 4.2 score on a scale | Standard Deviation 2.5 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Appetite | 3.1 score on a scale | Standard Deviation 3.2 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Nausea | 1.7 score on a scale | Standard Deviation 2.4 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Vomiting | 0.5 score on a scale | Standard Deviation 1.4 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Constipation | 1.5 score on a scale | Standard Deviation 2.6 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Drowsiness | 3.2 score on a scale | Standard Deviation 2.8 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Tiredness | 4.0 score on a scale | Standard Deviation 2.8 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Shortness of breath | 3.1 score on a scale | Standard Deviation 3 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Depression | 21 score on a scale | Standard Deviation 1.9 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Anxiety | 2.8 score on a scale | Standard Deviation 2.6 |
| A Single Arm, Prospective Study | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Distress | 2.4 score on a scale | Standard Deviation 2.5 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Shortness of breath | 2.8 score on a scale | Standard Deviation 2.7 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Sleep | 2.9 score on a scale | Standard Deviation 1.9 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Constipation | 1.4 score on a scale | Standard Deviation 2.4 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Well-being | 2.3 score on a scale | Standard Deviation 1.5 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Anxiety | 2.5 score on a scale | Standard Deviation 2.1 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Pain | 1.7 score on a scale | Standard Deviation 2 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Drowsiness | 1.8 score on a scale | Standard Deviation 2 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Strength | 3.4 score on a scale | Standard Deviation 2.4 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Depression | 2.3 score on a scale | Standard Deviation 2.3 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Appetite | 2.4 score on a scale | Standard Deviation 2.1 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Tiredness | 2.8 score on a scale | Standard Deviation 2.7 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Nausea | 0.8 score on a scale | Standard Deviation 1.5 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Distress | 2.3 score on a scale | Standard Deviation 2.5 |
| 6 Weeks | Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) | Vomiting | 0.6 score on a scale | Standard Deviation 1.3 |
p-value: 0.02t-test, 2 sided
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)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| A Single Arm, Prospective Study | 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) | Physical well-being | 20.6 score on a scale | Standard Deviation 5.2 |
| A Single Arm, Prospective Study | 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) | Social well-being | 20.4 score on a scale | Standard Deviation 4.3 |
| A Single Arm, Prospective Study | 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) | Emotional well-being | 15.8 score on a scale | Standard Deviation 5.4 |
| A Single Arm, Prospective Study | 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 well-being | 15.9 score on a scale | Standard Deviation 5.4 |
| A Single Arm, Prospective Study | 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) | Lung cancer scale | 17.5 score on a scale | Standard Deviation 3.6 |
| A Single Arm, Prospective Study | 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) | Trial outcome index | 90.2 score on a scale | Standard Deviation 17.2 |
| 6 Weeks | 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) | Lung cancer scale | 18.1 score on a scale | Standard Deviation 3.8 |
| 6 Weeks | 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) | Physical well-being | 23.3 score on a scale | Standard Deviation 1.6 |
| 6 Weeks | 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 well-being | 17.2 score on a scale | Standard Deviation 5.2 |
| 6 Weeks | 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) | Social well-being | 20.3 score on a scale | Standard Deviation 4.7 |
| 6 Weeks | 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) | Trial outcome index | 93.9 score on a scale | Standard Deviation 13.8 |
| 6 Weeks | 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) | Emotional well-being | 16.1 score on a scale | Standard Deviation 5 |
Comparison: Comparisons of repeated measures were made using paired sample t test, which compared subjects data at 2 different times: baseline and end of the study. A P value of 0.05 was considered statistically significantp-value: <0.05t-test, 2 sided
Secondary
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
Population: P value (calculated) =0.03
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A Single Arm, Prospective Study | Physical Well-Being Scores at Baseline and 6 Weeks | 20.6 score on a scale | Standard Deviation 5.2 |
| 6 Weeks | Physical Well-Being Scores at Baseline and 6 Weeks | 22.3 score on a scale | Standard Deviation 1.6 |
Secondary
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
Population: Number of adverse events reported between baseline and 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A Single Arm, Prospective Study | Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC | Total number of reported adverse events (AE) | 26 reported adverse events |
| A Single Arm, Prospective Study | Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC | Grade 1 AEs | 22 reported adverse events |
| A Single Arm, Prospective Study | Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC | Grade 2 AEs | 4 reported adverse events |
| A Single Arm, Prospective Study | Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC | Related to CH fomula | 3 reported adverse events |