Trial Outcomes & Findings for A Feasibility Study of Chinese Herbs to Manage Cancer-related Symptoms in Patients With Advanced NSCLC (NCT NCT02331394)

NCT ID: NCT02331394

Last Updated: 2020-06-23

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2020-06-23

Participant Flow

Participant milestones

Measure	Chinese Herbs Formula 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.
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Chinese Herbs Formula 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.

Overall Study Disease progression

1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Chinese Herbs Formula: Shu Yu Wan n=15 Participants 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.
Age, Continuous	63 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index (BMI) Low (<19.5)	2 participants n=5 Participants
Body Mass Index (BMI) Normal (19.6-24.5)	8 participants n=5 Participants
Body Mass Index (BMI) High (>24.5)	5 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG PS 0-1	12 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG PS 2-3	3 participants n=5 Participants
Smoking status Ex/never smoker	14 participants n=5 Participants
Smoking status Smoker	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	A Single Arm, Prospective Study n=26 Participants Participants received CH formula in 1 sachet or 4 capsules 3 times a day for 6 weeks	6 Weeks Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher score is considered better.
Feasibility of Using CH for Full-scale Future Research enrolled	15 participants	—
Feasibility of Using CH for Full-scale Future Research refused	6 participants	—
Feasibility of Using CH for Full-scale Future Research already taking some herbal supplement	5 participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	A Single Arm, Prospective Study n=14 Participants Participants received CH formula in 1 sachet or 4 capsules 3 times a day for 6 weeks	6 Weeks n=14 Participants Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher score is considered better.
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	23.3 score on a scale Standard Deviation 1.6
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	20.3 score on a scale Standard Deviation 4.7
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	16.1 score on a scale Standard Deviation 5.0
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	17.2 score on a scale Standard Deviation 5.2
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	18.1 score on a scale Standard Deviation 3.8
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	93.9 score on a scale Standard Deviation 13.8

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: P value (calculated) =0.03

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

Outcome measures

Measure	A Single Arm, Prospective Study n=14 Participants Participants received CH formula in 1 sachet or 4 capsules 3 times a day for 6 weeks	6 Weeks n=14 Participants Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher score is considered better.
Physical Well-Being Scores at Baseline and 6 Weeks	20.6 score on a scale Standard Deviation 5.2	22.3 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Number of adverse events reported between 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)

Outcome measures

Measure	A Single Arm, Prospective Study n=15 Participants Participants received CH formula in 1 sachet or 4 capsules 3 times a day for 6 weeks	6 Weeks Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher score is considered better.
Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC Total number of reported adverse events (AE)	26 reported adverse events	—
Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC Grade 1 AEs	22 reported adverse events	—
Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC Grade 2 AEs	4 reported adverse events	—
Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC Related to CH fomula	3 reported adverse events	—

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: P value calculated

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.

Outcome measures

Measure	A Single Arm, Prospective Study n=14 Participants Participants received CH formula in 1 sachet or 4 capsules 3 times a day for 6 weeks	6 Weeks n=14 Participants Functional Assessment of Cancer Therapy - Lung (FACT-L) subscales scores. Higher score is considered better.
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Sleep	3.0 score on a scale Standard Deviation 3.2	2.9 score on a scale Standard Deviation 1.9
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	2.3 score on a scale Standard Deviation 1.5
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Pain	2.2 score on a scale Standard Deviation 2.2	1.7 score on a scale Standard Deviation 2.0
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Strength	4.2 score on a scale Standard Deviation 2.5	3.4 score on a scale Standard Deviation 2.4
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Appetite	3.1 score on a scale Standard Deviation 3.2	2.4 score on a scale Standard Deviation 2.1
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Nausea	1.7 score on a scale Standard Deviation 2.4	0.8 score on a scale Standard Deviation 1.5
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Vomiting	0.5 score on a scale Standard Deviation 1.4	0.6 score on a scale Standard Deviation 1.3
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Constipation	1.5 score on a scale Standard Deviation 2.6	1.4 score on a scale Standard Deviation 2.4
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Drowsiness	3.2 score on a scale Standard Deviation 2.8	1.8 score on a scale Standard Deviation 2.0
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Tiredness	4.0 score on a scale Standard Deviation 2.8	2.8 score on a scale Standard Deviation 2.7
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Shortness of breath	3.1 score on a scale Standard Deviation 3.0	2.8 score on a scale Standard Deviation 2.7
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Depression	21 score on a scale Standard Deviation 1.9	2.3 score on a scale Standard Deviation 2.3
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Anxiety	2.8 score on a scale Standard Deviation 2.6	2.5 score on a scale Standard Deviation 2.1
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS) Distress	2.4 score on a scale Standard Deviation 2.5	2.3 score on a scale Standard Deviation 2.5

Adverse Events

A Single Arm, Prospective Study

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	A Single Arm, Prospective Study n=15 participants at risk 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.
Gastrointestinal disorders Nausea	33.3% 5/15 • Number of events 5 • 6 weeks not different
Gastrointestinal disorders constipation	26.7% 4/15 • Number of events 4 • 6 weeks not different
Gastrointestinal disorders Diarrhea	13.3% 2/15 • Number of events 2 • 6 weeks not different
Gastrointestinal disorders Loss of appetite	20.0% 3/15 • Number of events 3 • 6 weeks not different
Infections and infestations Infections	13.3% 2/15 • Number of events 2 • 6 weeks not different
Blood and lymphatic system disorders Thrombocytopenia	6.7% 1/15 • Number of events 1 • 6 weeks not different
General disorders Edema	13.3% 2/15 • Number of events 2 • 6 weeks not different
Musculoskeletal and connective tissue disorders Dermatitis	13.3% 2/15 • Number of events 2 • 6 weeks not different
Respiratory, thoracic and mediastinal disorders cough	20.0% 3/15 • Number of events 3 • 6 weeks not different
Gastrointestinal disorders vomiting	13.3% 2/15 • Number of events 2 • 6 weeks not different

Additional Information

Goulnar Kasymjanova

Jewish General Hospita;

Phone: 514-340-8222

Email: gkasymja@jgh.mcgill.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place