Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

Herbal and Botanical

All Drugs and Chemicals

Chinese Yam

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 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.

Chinese herbs formula: Shu Yu Wan

Thomas Jagoe, MD

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.

This is a feasibility study designed to see if the main study can be done.

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

A Feasibility Study of Chinese Herbs (CH) to Manage Cancer-related Symptoms in Patients With Advanced Non-small-cell- Lung Cancer (NSCLC)

Number of participants consented over the total number of approached for the study.

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.

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

Presence of new symptoms or changes in blood tests suggestive of new toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)

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.

Lady Davis Institute

A single-arm, prospective study design was chosen to test the feasibility and acceptability of using the selected CH formula in patients with stage 4 NSCLC at our center. Patients with stage 4 NSCLC were eligible if they had Eastern Cooperative Oncology Group performance status of 0-2 and had not used CHs. In addition, to ensure that no CH-related side effects were misattributed to chemotherapy, only patients who had completed at least one cycle of their current standard chemotherapy and were clinically stable were eligible. Patients who were not on treatment were also eligible if there was no plan to recommence the treatment within the next 6 weeks. To safeguard those who were perceived to be potentially at increased risk of side effects from CHs, patients with active brain metastases, abnormal liver function or those taking tyrosine kinase inhibitors, immunosuppressive drugs, anticonvulsant and anticoagulant medications were excluded.

A Single Arm, Prospective Study

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.

Chinese Herbs Formula: Shu Yu Wan

Age at the time of enrollment treated as a continues variable

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Low (<19.5)

Normal (19.6-24.5)

High (>24.5)

Body mass index measured at the baseline and categorized as:

Low \<19.5 kg/m2 Normal 19.6-24.5 kg/m2 High \>24.6 kg/m2

Body Mass Index (BMI)

ECOG PS 0-1

ECOG PS 2-3

Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction

1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours

Eastern Cooperative Oncology Group (ECOG) Performance Status

Ex/never smoker

Smoker

Smokers had a history of consuming at least 5 cigarettes a day in the last 2 years; Ex-smokers are those who quit smoking 2 or more years ago; Non-smoker are those who never smoke a cigarette during the life time. Fo purpose of this study participants categorized as ex/never smokers versus smokers

Smoking status

This is a small study in a single centre leading to small number of subjects Caveat: further randomized controlled study needed to confirm the safety and benefit of of CH formula.

Goulnar Kasymjanova

enrolled

refused

already taking some herbal supplement

Participants received CH formula in 1 sachet or 4 capsules 3 times a day for 6 weeks

Feasibility of Using CH for Full-scale Future Research

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 significant

Physical well-being

Social well-being

Emotional well-being

Functional well-being

Lung cancer scale

Trial outcome index

The Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher scores is considered better.

Baseline

Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher score is considered better.

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 (PWB) of the Functional Assessment of Cancer Therapy - Lung (FACT-L), range of the score 0-28, with 0 being best and 28 being worse

Physical Well-Being Scores at Baseline and 6 Weeks

Total number of reported adverse events (AE)

Grade 1 AEs

Grade 2 AEs

Related to CH fomula

Number of adverse events reported between baseline and 6 weeks

Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC

Sleep

Well-being

Pain

Strength

Appetite

Nausea

Vomiting

Constipation

Drowsiness

Tiredness

Shortness of breath

Depression

Anxiety

Distress

Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS)

A single-arm, prospective study design was chosen to test the feasibility and acceptability of using the selected Chinese herbs (CH) formula in patients with stage 4 non-small cell lung cancer (NSCLC). All participants will be offered the choice of taking the CH formula in capsules or sachets in addition to standard of care. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for 6 weeks.

Spots Global Cancer Trial Database for chinese herbs formula: shu yu wan