Lung CancerCHNCT02331394
A Feasibility Study of Chinese Herbs to Manage Cancer-related Symptoms in Patients With Advanced NSCLC
A study testing Chinese herbs formula: Shu Yu Wan in people with Lung Cancer, run by Lady Davis Institute at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Chinese herbs formula: Shu Yu Wan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stages 4
- ECOG performance ≤ 3
- Life expectancy greater than ≥ 3 months
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Peter Brojge Lung Cancer Center, Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: A Feasibility Study of Chinese Herbs (CH) to Manage Cancer-related Symptoms in Patients With Advanced Non-small-cell- Lung Cancer (NSCLC)
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Chinese herbs formula: Shu Yu Wan
- Keywords
- Chinese herbs, lung cancer, quality of life
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbs formula: Shu Yu WanDietary supplement
Also called Chinese Yam Pill
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.
| Study group | Role | What they receive |
|---|---|---|
| Chinese herbs formula: Shu Yu Wan | Experimental | 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. Receives: Dietary Supplement: Chinese herbs formula: Shu Yu Wan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Using CH for Full-scale Future Research
Number of participants consented over the total number of approached for the study.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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
Measured: 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)
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a feasibility study designed to see if the main study can be done.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Jagoe, Lady Davis Institute
- Investigators
- Thomas Jagoe, MD, Principal investigator, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331394
- Sponsor's protocol ID
- JGH-14-150
- Acronym
- CH
- Status last verified
- Jun 2020
- First submitted
- 3 Jan 2015
- Last updated
- 23 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publication in peer-reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Chinese Herbs (CH) to Manage Cancer-related Symptoms in Patients With Advanced Non-small-cell- Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02331394
- Acronym / sponsor ID
- CH / JGH-14-150
- Conditions
- Lung Cancer
- Keywords
- Chinese herbs, lung cancer, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Posted 23 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a feasibility study designed to see if the main study can be done.
| Arm | Type | Receives |
|---|---|---|
| Chinese herbs formula: Shu Yu Wan | Experimental | Dietary Supplement: Chinese herbs formula: Shu Yu WanAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stages 4
- ECOG performance ≤ 3
- Life expectancy greater than ≥ 3 months
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese herbs formula: Shu Yu WanAlso: Chinese Yam PillThe 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. | Dietary supplement | Chinese herbs formula: Shu Yu Wan |
Primary outcome
Feasibility of Using CH for Full-scale Future Research
Time frame: 1 year
Number of participants consented over the total number of approached for the study.
4 secondary outcomes
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)
Time frame: Baseline and 6 weeks
Physical Well-Being Scores at Baseline and 6 Weeks
Time frame: Baseline and 6 weeks
Safety of Using Chinese Herb Formula in Patients With Advanced NSCLC
Time frame: Baseline and 6 weeks
Change From the Baseline in Symptoms on the Edmonton Symptom Assessment System (ESAS)
Time frame: Baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Publication in peer-reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Jagoe, MD principal investigator
Lady Davis Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese herbs formula: Shu Yu Wan in people with Lung Cancer, run by Lady Davis Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Using CH for Full-scale Future Research (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.