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Study protocol
Effects of Traditional Chinese Medicine Combined with Chemotherapy for Extensive-stage Small-cell Lung Cancer Patients on Improving Oncologic Survival: Study Protocol of a Multicenter, Randomized, Single-blind, Placebo-controlled Trial
GuoWang Yang
Beijing Hospital of Traditional Chinese Medine affiliated with Capital Medical University
Corresponding Author
ORCiD: https://orcid.org/0000-0002-0799-3864
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Background: Extensive-stage small-cell lung cancer (ES-SCLC) is characterized by extensive metastases, aggressive progression and poor prognosis. Chemotherapy is applied as a preferred first-line regimen for ES-SCLC, but inadequate for improving its overall survival. Traditional Chinese medicine (TCM) is widely used in the clinical practice of ES-SCLC for its synergy with chemotherapy. However, there is still no substantial evidence to prove that TCM can effectively improve the long-term efficacy of ES-SCLC patients. The study intends to determine whether the TCM with chemotherapy can improve the overall survival (OS) in treating with ES-SCLC when compared with chemotherapy alone.
Method/design: A multicenter, randomized, single-blind, placebo-controlled clinical trial will be conducted to determine whether the TCM granules combined with chemotherapy can improve the OS of ES-SCLC. 270 participants will randomly receive 4-6 cycles (21days per cycle) of chemotherapy plus TCM granules or placebo. The primary outcome measures is OS. The secondary outcome measures includes progression-free survival (PFS), objective response rate (ORR), quality of life (QoL) and tumor markers. Visits will be performed at the end of each cycle during the treatment period and then every 3 months in the follow-up period until the patients’ death or study completion.
Discussion: The study’s result will provide a high-level evidence for TCM granules using with chemotherapy on the first-line treatment of ES-SCLC.
Trial registration: Chinese Clinical Trial Registry, No. ChiCTR1900022991, registered 6 May 2019 (prospective registration).
Keywords
Extensive-stage small-cell lung cancer (ES-SCLC), traditional Chinese medicine (TCM), randomized controlled trial (RCT), overall survival (OS), quality of life
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Effects of Traditional Chinese Medicine Combined with Chemotherapy for Extensive-stage Small-cell Lung Cancer Patients on Improving Oncologic Survival: Study Protocol of a Multicenter, Randomized, Single-blind, Placebo-controlled Trial
GuoWang Yang
Beijing Hospital of Traditional Chinese Medine affiliated with Capital Medical University
Corresponding Author
ORCiD: https://orcid.org/0000-0002-0799-3864
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 12 Jan, 2021
No community comments so far
Editor assigned
On 05 Jan, 2021
Submission checks complete
On 05 Jan, 2021
First submitted
On 12 Sep, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Extensive-stage small-cell lung cancer (ES-SCLC) is characterized by extensive metastases, aggressive progression and poor prognosis. Chemotherapy is applied as a preferred first-line regimen for ES-SCLC, but inadequate for improving its overall survival. Traditional Chinese medicine (TCM) is widely used in the clinical practice of ES-SCLC for its synergy with chemotherapy. However, there is still no substantial evidence to prove that TCM can effectively improve the long-term efficacy of ES-SCLC patients. The study intends to determine whether the TCM with chemotherapy can improve the overall survival (OS) in treating with ES-SCLC when compared with chemotherapy alone.
Method/design: A multicenter, randomized, single-blind, placebo-controlled clinical trial will be conducted to determine whether the TCM granules combined with chemotherapy can improve the OS of ES-SCLC. 270 participants will randomly receive 4-6 cycles (21days per cycle) of chemotherapy plus TCM granules or placebo. The primary outcome measures is OS. The secondary outcome measures includes progression-free survival (PFS), objective response rate (ORR), quality of life (QoL) and tumor markers. Visits will be performed at the end of each cycle during the treatment period and then every 3 months in the follow-up period until the patients’ death or study completion.
Discussion: The study’s result will provide a high-level evidence for TCM granules using with chemotherapy on the first-line treatment of ES-SCLC.
Trial registration: Chinese Clinical Trial Registry, No. ChiCTR1900022991, registered 6 May 2019 (prospective registration).
Figure 1
Figure 2