Carcinoma, Non-Small-Cell LungPhase 4NCT03712969
Shenlingcao Oral Liquid for Patients With Stage II or IIIA NSCLC
A Phase 4 study testing Shenlingcao Oral Liquid in people with Carcinoma, Non-Small-Cell Lung and Chemotherapy, Adjuvant, run by West China Hospital at 1 site in China.
Trial summary
In this study, a pragmatic, open labelled, multi-center randomized controlled trial will be conducted. The study population are stage II and IIIA NSCLC patients undergoing R0 resection and will be scheduled for adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Chemotherapy, Adjuvant
- What is being tested?
- Shenlingcao Oral Liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 527 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2018to 4 May 2023
- Phase
- Phase 4
- 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
- Age 18 or older;
- Pathological diagnosis of patients with stage II, III A primary NSCLC;
- R0 resection has been accepted;
- Received adjuvant chemotherapy or adjuvant chemotherapy for the first time after surgery;
- Informed consent has been signed.
Who cannot join
- Incorporation of other malignant tumors (such as leukemia, liver cancer, etc.);
- Patients with unclear pathological types;
- Patients with unclear pathological staging;
- Preserved Shenlingcao Oral Liquid before R0 resection surgery;
- Received immunotherapy or targeted therapy before R0 resection surgery;
- Radiotherapy and chemotherapy before R0 resection surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shenlingcao Oral Liquid for Patients With Stage II or IIIA Non-small Cell Lung Cancer Receiving Radical Resection: A Pragmatic, Multicenter Randomized Controlled Trial
In this study, a pragmatic, open labelled, multi-center randomized controlled trial will be conducted. The study population are stage II and IIIA NSCLC patients undergoing R0 resection and will be scheduled for adjuvant chemotherapy. Potentially eligible patients will be screened by the research clinicians and requested to complete and sign a consent form before enrolment. Eligible patients who consent to participate will be randomly assigned to the intervention group (patients receive conventional treatment and Shenlingcao oral liquid) and the control group (patients only receive conventional treatment) designed dynamic stratified block randomized algorithm via a central randomization system for clinical research using 1:1 ratio.
The intervention and control group will be enrolled before the first chemoradiation. Non-allelic follow-up will be conducted in this study and terminated when the last enrolled patient follow up to 24 months. Prospectively collected information from patients, including baseline, chemoradiation, use of Shenlingcao Oral Liquid and the other complementary drugs, and various outcome measures (the questionnaire of EORTC QLQ, death, tumor recurrence, tumor metastasis, and chemotherapy-induced side effects of the blood system, etc.). Follow-up points included: Baseline (before giving chemotherapy), 2-3 days after each chemotherapy cycle, and 6,12,18,24,30,36 months after enrollment.
- Being tested
- Shenlingcao Oral Liquid
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenlingcao Oral LiquidDrug
Patients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day. Receives: Drug: Shenlingcao Oral Liquid |
| Control group | No intervention | Patients receive conventional adjuvant chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of life assessed by Research and Treatment of Cancer Quality of Life Questionnaire
We investigated the long-term quality of life of postoperative lung cancer patients, utilizing the disease-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) C30 to assess the quality of life among these patients. The EORTC QLQ-C30 is composed of 9 multi-item scales including 5 functional scales, 3 symptom scales, a global quality-of-life scale, and 6 single-item symptom measures. All the items are scored on a scale of 0 to 100, with a high score on a functional or the global quality-of-life scale representing a high level of functioning or quality of life and a high score on a symptom scale representing a high level of symptoms.
Measured: 2-3 days after the fourth chemotherapy cycle
Secondary outcomes (3)
The completion rate of chemotherapy
Whether the patient completed four cycles of chemotherapy.
Measured: 2-3 days after the fourth chemotherapy cycle
Disease-free survival
Disease-free survival (DFS) refers to the time from the operation to the time that there is evidence of tumor recurrence / metastasis or any cause of death (the DFS of lost follow-up patients is the last follow-up time). The tumor recurrence / metastasis needs to be diagnosed based on imaging or pathological evidence.
Measured: 24 months after enrollment
Remission of hematological toxicity caused by chemotherapeutic drugs
Remission of hematological toxicity caused by chemotherapeutic drugs, using WHO grading of acute and subacute toxicity. Hematological toxicity is observed from four hematological indicators, including hemoglobin, white blood cells, granulocytes and platelets. A 5-grade system of severity levels is recommended for general use: grades 0-4 . The higher the level, the greater the toxic reaction. The most severe of the four indicators is the patient's hematological toxicity level.
Measured: 2-3 days after the fourth chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start5 Nov 2018
- Primary completion14 Mar 2022
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Xin, West China Hospital
- Investigators
- Xin Sun, PhD, Study director, The West China Hospital of Sichuan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712969
- Sponsor's protocol ID
- 20181009
- Status last verified
- May 2024
- First submitted
- 9 Oct 2018
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Y, Luo X, Liu J, Ma Y, Tan J, Wang W, Hu J, Fu X, Xu L, Yu F, Xu S, Ma H, Yu X, You Q, Wang Z, Li L, Zhang X, Sun X. Shenlingcao oral liquid for patients with non-small cell lung cancer receiving adjuvant chemotherapy after radical resection: A multicenter randomized controlled trial. Phytomedicine. 2023 May;113:154723. doi: 10.1016/j.phymed.2023.154723. Epub 2023 Feb 21.
PubMed 36871476
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shenlingcao Oral Liquid for Patients With Stage II or IIIA Non-small Cell Lung Cancer Receiving Radical Resection: A Pragmatic, Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03712969
- Acronym / sponsor ID
- 20181009
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 19 Oct 2018 (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.
In this study, a pragmatic, open labelled, multi-center randomized controlled trial will be conducted. The study population are stage II and IIIA NSCLC patients undergoing R0 resection and will be scheduled for adjuvant chemotherapy. Potentially eligible patients will be screened by the research clinicians and requested to complete and sign a consent form before enrolment. Eligible patients who consent to participate will be randomly assigned to the intervention group (patients receive conventional treatment and Shenlingcao oral liquid) and the control group (patients only receive conventional treatment) designed dynamic stratified block randomized algorithm via a central randomization system for clinical research using 1:1 ratio.
The intervention and control group will be enrolled before the first chemoradiation. Non-allelic follow-up will be conducted in this study and terminated when the last enrolled patient follow up to 24 months. Prospectively collected information from patients, including baseline, chemoradiation, use of Shenlingcao Oral Liquid and the other complementary drugs, and various outcome measures (the questionnaire of EORTC QLQ, death, tumor recurrence, tumor metastasis, and chemotherapy-induced side effects of the blood system, etc.). Follow-up points included: Baseline (before giving chemotherapy), 2-3 days after each chemotherapy cycle, and 6,12,18,24,30,36 months after enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Shenlingcao Oral LiquidPatients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day. |
| Control group | No intervention | –Patients receive conventional adjuvant chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older;
- Pathological diagnosis of patients with stage II, III A primary NSCLC;
- R0 resection has been accepted;
- Received adjuvant chemotherapy or adjuvant chemotherapy for the first time after surgery;
- Informed consent has been signed.
Key exclusion criteria (6 listed)
- Incorporation of other malignant tumors (such as leukemia, liver cancer, etc.);
- Patients with unclear pathological types;
- Patients with unclear pathological staging;
- Preserved Shenlingcao Oral Liquid before R0 resection surgery;
- Received immunotherapy or targeted therapy before R0 resection surgery;
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 |
|---|---|---|
| Shenlingcao Oral LiquidPatients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day. | Drug | Intervention group |
Primary outcome
The quality of life assessed by Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: 2-3 days after the fourth chemotherapy cycle
We investigated the long-term quality of life of postoperative lung cancer patients, utilizing the disease-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) C30 to assess the quality of life among these patients. The EORTC QLQ-C30 is composed of 9 multi-item scales including 5 functional scales, 3 symptom scales, a global quality-of-life scale, and 6 single-item symptom measures. All the items are scored on a scale of 0 to 100, with a high score on a functional or the global quality-of-life scale representing a high level of functioning or quality of life and a high score on a symptom scale representing a high level of symptoms.
3 secondary outcomes
The completion rate of chemotherapy
Time frame: 2-3 days after the fourth chemotherapy cycle
Disease-free survival
Time frame: 24 months after enrollment
Remission of hematological toxicity caused by chemotherapeutic drugs
Time frame: 2-3 days after the fourth chemotherapy cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 36871476Liu Y, Luo X, Liu J, Ma Y, Tan J, Wang W, Hu J, Fu X, Xu L, Yu F, Xu S, Ma H, Yu X, You Q, Wang Z, Li L, Zhang X, Sun X. Shenlingcao oral liquid for patients with non-small cell lung cancer receiving adjuvant chemotherapy after radical resection: A multicenter randomized controlled trial. Phytomedicine. 2023 May;113:154723. doi: 10.1016/j.phymed.2023.154723. Epub 2023 Feb 21.
- Individual participant dataSharing planned: No
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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.
Xin Sun, PhD study director
The West China Hospital of Sichuan university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shenlingcao Oral Liquid in people with Carcinoma, Non-Small-Cell Lung and Chemotherapy, Adjuvant, run by West China Hospital at 1 site in China.
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 5 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 9 May 2024. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The quality of life assessed by Research and Treatment of Cancer Quality of Life Questionnaire (time frame: 2-3 days after the fourth chemotherapy cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03712969, which also lists 1 linked publication.
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 9 May 2024.