Metastatic NSCLCCH:IINCT04615884
Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients
A study testing Chinese herbs formula: Shu Yu Wan in people with Metastatic NSCLC, run by Lady Davis Institute at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate whether Chinese Herb supplements lead to a measurable improvement in symptoms commonly experienced by patients with advanced stage lung cancer and an improvement in quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic NSCLC
- What is being tested?
- Chinese herbs formula: Shu Yu Wan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients must meet the following criteria for study entry:
- Signed informed consent
- Ability to comply with protocol
- Aged ≥18 years
- Histologically or cytologically documented metastatic NSCLC (American Joint Committee on Cancer [AJCC] staging system)
- Prior chemotherapy or radiotherapy is allowed provided the patient has recovered from any toxic effects
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- Either off chemotherapy with no plans to start within the next 8 weeks OR on first or second line systemic anti-cancer treatment for NSCLC and completed at least 1 cycle of their current treatment prior to randomization. Permitted chemotherapy regimens are: standard systemic chemotherapy, targeted therapy, immunotherapy or any combinations of the three
- Karnofsky performance status of ≥60
- Life expectancy ≥ 12 weeks
- Adequate hematologic and end-organ function defined by the following laboratory results obtained within 14 days prior to the first study eligibility):
- ANC 1. 3 -3.5 x^109/L WBC counts 4.0 - 11 x^109/L Platelet count 150 - 400 x^109/L Hemoglobin 90 -150 g/dL Liver function tests AST ≤ 1.5 x ULN / ALT ≤ 1.5 x ULN L Serum bilirubin 3.0-17.0 x U/L INR ≤1.5 x ULN Creatinine clearance 50-120 mL/min
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study entry:
- Active or untreated central nervous system metastases
- Uncontrolled pleural effusion
- Patients or families who do not speak English or French
- Abnormal liver function as defined above
- Taking regular anti-convulsants, Coumadin or related anti-coagulant
- 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), or other immunosuppressive or anti-coagulant that metabolized by liver.
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: Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients: a Randomized Double-blind Placebo- Controlled Trial
The purpose of this study is to evaluate whether Chinese Herb supplements lead to a measurable improvement in symptoms commonly experienced by patients with advanced stage lung cancer and an improvement in quality of life. In our previously conducted single-arm observational study we found significant improvement in physical well-being, tiredness and drowsiness with no evidence of increased toxicity even in those on cytotoxic chemotherapy. Based on the encouraging results of this study we plan to move to a placebo-controlled study using the same Chinese Herb formula.
Read the detailed description
Despite advances in the design and administration of anti-cancer therapies over recent years, the overall 5-year survival rate for patients with advanced stage lung cancer is 2-4%. These patients frequently suffer a range of different symptoms related to both their disease and it's treatment. As a result, there is a pressing need for research into treatments that may improve their symptoms as well as their quality of life (QOL).
An increasing body of evidence suggests that complementary medicine, including carefully selected combinations of Chinese Herbs (CH), may exert beneficial effects for cancer patients in many ways. The literature suggests that CH combined with chemotherapy can improve survival rates, immediate tumor response, performance status and QOL for those with locally advanced and metastatic disease.
The Shu Yu Wan (SYW) formula used in the feasibility study which demonstrated a significant improvement in symptoms and quality of life will also be employed in this interventional study. THe SYW formula consists of 23 natural Chinese herbs.
This is a randomized, double-blinded, placebo-controlled, parallel-arm clinical trial with a 1:1 allocation ratio for investigating the efficacy and safety of SYW formula for the treatment of lung cancer symptoms. Patients in both groups will receive formula or placebo at a fixed dose for 6 weeks.
After completion of study medication, the treatment will be unblinded and patients randomized to placebo will be offered to cross-over to SYW and will repeat visits Week 0 \& Week 6. Patients will be closely monitored for safety and tolerability throughout the study.
- Conditions
- Metastatic NSCLC
- Being tested
- Chinese herbs formula: Shu Yu Wan, Placebo capsules
- Keywords
- NSCLC, Metastatic, Symptom management,
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
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
Shu Yu Wan Formula is a combination of 23 natural chinese herbs.This formula may be used to relieve chemotherapeutic side effects or cancer-related symptoms.
Placebo capsulesOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Chinese herbs formula: Shu Yu Wan | Experimental | Participants will receive Shu Yu Wan capsules, to take 3 times daily for 6 weeks. Receives: Dietary Supplement: Chinese herbs formula: Shu Yu Wan |
| Placebo | Placebo comparator | Participants will receive capsules to take 3 times daily for 6 weeks. Receives: Other: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Well-Being Scores at Baseline and 6 Weeks
The primary objective is to compare the change in patient reported Physical Well-Being (PWB) subscale of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. 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.
Measured: Baseline and 6 weeks
Secondary outcomes (1)
Fatigue scores at Baseline and 6 weeks
The secondary objective is to compare change in Fatigue subscale on the Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) questionnaire. Symptoms and health status will be assessed using the Functional Assessment of Cancer Therapy-lung (FACT-L), and Functional Assessment for Chronic Illness Therapy - Fatigue (FACIT-F). The FACT-L is a 36-item self-report questionnaire that evaluates quality of life in lung cancer patients. Twenty-nine items measure physical, social, emotional and functional well-being; The final 7 items constitute the Lung Cancer Symptom Scale (LCSS). The FACIT-F Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued).
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 posted4 Nov 2020
- Study startMar 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2024 (estimated)
Why it stopped: unable to secure the funding despite multiple grant applications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic NSCLCStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615884
- Sponsor's protocol ID
- CH:II
- Acronym
- CH:II
- Status last verified
- Jul 2025
- First submitted
- 29 Oct 2020
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in peer-reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Chinese Herbal Formula Shu Yu Wan in Lung Cancer Patients: a Randomized Double-blind Placebo- Controlled Trial
- ClinicalTrials.gov ID
- NCT04615884
- Acronym / sponsor ID
- CH:II / CH:II
- Conditions
- Metastatic NSCLC
- Keywords
- NSCLC, Metastatic, Symptom management,
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to secure the funding despite multiple grant applications
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether Chinese Herb supplements lead to a measurable improvement in symptoms commonly experienced by patients with advanced stage lung cancer and an improvement in quality of life. In our previously conducted single-arm observational study we found significant improvement in physical well-being, tiredness and drowsiness with no evidence of increased toxicity even in those on cytotoxic chemotherapy. Based on the encouraging results of this study we plan to move to a placebo-controlled study using the same Chinese Herb formula.
Detailed description
Despite advances in the design and administration of anti-cancer therapies over recent years, the overall 5-year survival rate for patients with advanced stage lung cancer is 2-4%. These patients frequently suffer a range of different symptoms related to both their disease and it's treatment. As a result, there is a pressing need for research into treatments that may improve their symptoms as well as their quality of life (QOL).
An increasing body of evidence suggests that complementary medicine, including carefully selected combinations of Chinese Herbs (CH), may exert beneficial effects for cancer patients in many ways. The literature suggests that CH combined with chemotherapy can improve survival rates, immediate tumor response, performance status and QOL for those with locally advanced and metastatic disease.
The Shu Yu Wan (SYW) formula used in the feasibility study which demonstrated a significant improvement in symptoms and quality of life will also be employed in this interventional study. THe SYW formula consists of 23 natural Chinese herbs.
This is a randomized, double-blinded, placebo-controlled, parallel-arm clinical trial with a 1:1 allocation ratio for investigating the efficacy and safety of SYW formula for the treatment of lung cancer symptoms. Patients in both groups will receive formula or placebo at a fixed dose for 6 weeks.
After completion of study medication, the treatment will be unblinded and patients randomized to placebo will be offered to cross-over to SYW and will repeat visits Week 0 \& Week 6. Patients will be closely monitored for safety and tolerability throughout the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese herbs formula: Shu Yu Wan | Experimental | Dietary Supplement: Chinese herbs formula: Shu Yu WanParticipants will receive Shu Yu Wan capsules, to take 3 times daily for 6 weeks. |
| Placebo | Placebo comparator | Other: Placebo capsulesParticipants will receive capsules to take 3 times daily for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent
- Ability to comply with protocol
- Aged ≥18 years
- Histologically or cytologically documented metastatic NSCLC (American Joint Committee on Cancer [AJCC] staging system)
- Prior chemotherapy or radiotherapy is allowed provided the patient has recovered from any toxic effects
Key exclusion criteria (7 listed)
- Active or untreated central nervous system metastases
- Uncontrolled pleural effusion
- Patients or families who do not speak English or French
- Abnormal liver function as defined above
- Taking regular anti-convulsants, Coumadin or related anti-coagulant
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 WanShu Yu Wan Formula is a combination of 23 natural chinese herbs.This formula may be used to relieve chemotherapeutic side effects or cancer-related symptoms. | Dietary supplement | Chinese herbs formula: Shu Yu Wan |
| Placebo capsulesPlacebo | Other | Placebo |
Primary outcome
Physical Well-Being Scores at Baseline and 6 Weeks
Time frame: Baseline and 6 weeks
The primary objective is to compare the change in patient reported Physical Well-Being (PWB) subscale of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. 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.
1 secondary outcome
Fatigue scores at Baseline and 6 weeks
Time frame: Baseline and 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Metastatic NSCLC, 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 11 inclusion and 7 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: withdrawn, as of the sponsor's last update on 28 Jul 2025. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Physical Well-Being Scores at Baseline and 6 Weeks (time frame: Baseline and 6 weeks). 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 28 Jul 2025.