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Study protocol
Yabin Gong
Corresponding Author
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Background: Comprehensive rehabilitation therapy based on traditional Chinese medicine (TCM) has been widely applied in various cancer treatments in China. Thus far, Chinese herbal medicine (CHM) has been shown to be effective in reducing the adverse effects of chemotherapy and improving the quality of life (QoL) during chemotherapy. The purpose of the present study is to compare the effects of CHM plus Liu Zi Jue (LZJ) exercises with CHM plus rehabilitation education and placebo plus rehabilitation education in patients who have undergone complete resection for non-small-cell lung cancer (NSCLC) followed by postoperative adjuvant chemotherapy. Methods and design: A multi-center, randomized clinical trial will be performed with 354 stage Ib-IIIa NSCLC patients in 5 centers in China. Patients satisfying the inclusion criteria will be randomly divided into 3 groups according to a 1:1:1 ratio, intervention group A (IGA), intervention group B (IGB) and control group (CG). Each group will receive adjuvant platinum-based doublet chemotherapy for a total of 4 cycles. IGA participants will receive chemotherapy combined with CHM and LZJ exercises, IGB participants will receive chemotherapy combined with CHM and rehabilitation education, and CG participants will receive chemotherapy combined with placebo and rehabilitation education. The herbal treatment patients will be given granules daily and LZJ exercises will be performed 4 times a week during chemotherapy. The primary outcome is QoL, which will be assessed with the EORTC (The European Organization for Research and Treatment of Cancer)-QLQ-C43 scale each cycle. The secondary outcomes include the 2-year disease-free survival rate, disease-free survival (DFS), TCM symptoms, tumor markers, safety and adverse events. After treatment, the patients will be followed up every 3 months within 2 years and every 6 months after 2 years until disease recurrence and/or metastasis. Discussion: Our previous study reported that CHM in combination with chemotherapy could lower the overall incidence of adverse events but increased digestive and gastrointestinal (GI) side effects compared with chemotherapy alone in postoperative NSCLC patients. This study will lay a foundation for the effectiveness of chemotherapy with or without a comprehensive rehabilitation program for QoL in patients with postoperative NSCLC.
Keywords
Chinese herbal medicine; Liu Zi Jue exercises; Rehabilitation; Non-small-cell lung cancer; Quality of Life
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CURRENT STATUS: Published
View the published article at Trials.
Version 2
Posted 11 Oct, 2019
No community comments so far
Review #2 received
Received 11 Feb, 2020
Editorial decision: Accept
On 11 Feb, 2020
Reviewer #2 agreed
On 28 Jan, 2020
Review #1 received
Received 21 Nov, 2019
Reviewer #1 agreed
On 20 Nov, 2019
Reviewers invited
Invitations sent on 10 Oct, 2019
Editor assigned
On 09 Oct, 2019
Submission checks complete
On 08 Oct, 2019
No comments provided
Editorial decision: Minor revision
On 11 Sep, 2019
Review #1 received
Received 03 Sep, 2019
Reviewer #1 agreed
On 17 May, 2019
Reviewers invited
Invitations sent on 16 May, 2019
Editor assigned
On 11 May, 2019
Submission checks complete
On 01 Feb, 2019
First submitted
On 29 Jan, 2019
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Subject Areas
General Medicine
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A new preprint design is coming!
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See the published version of this preprint at Trials.
This is a preprint, 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
Yabin Gong
Corresponding Author
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: Published
View the published article at Trials.
Version 2
Posted 11 Oct, 2019
No community comments so far
Review #2 received
Received 11 Feb, 2020
Editorial decision: Accept
On 11 Feb, 2020
Reviewer #2 agreed
On 28 Jan, 2020
Review #1 received
Received 21 Nov, 2019
Reviewer #1 agreed
On 20 Nov, 2019
Reviewers invited
Invitations sent on 10 Oct, 2019
Editor assigned
On 09 Oct, 2019
Submission checks complete
On 08 Oct, 2019
No comments provided
Editorial decision: Minor revision
On 11 Sep, 2019
Review #1 received
Received 03 Sep, 2019
Reviewer #1 agreed
On 17 May, 2019
Reviewers invited
Invitations sent on 16 May, 2019
Editor assigned
On 11 May, 2019
Submission checks complete
On 01 Feb, 2019
First submitted
On 29 Jan, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
General Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background: Comprehensive rehabilitation therapy based on traditional Chinese medicine (TCM) has been widely applied in various cancer treatments in China. Thus far, Chinese herbal medicine (CHM) has been shown to be effective in reducing the adverse effects of chemotherapy and improving the quality of life (QoL) during chemotherapy. The purpose of the present study is to compare the effects of CHM plus Liu Zi Jue (LZJ) exercises with CHM plus rehabilitation education and placebo plus rehabilitation education in patients who have undergone complete resection for non-small-cell lung cancer (NSCLC) followed by postoperative adjuvant chemotherapy. Methods and design: A multi-center, randomized clinical trial will be performed with 354 stage Ib-IIIa NSCLC patients in 5 centers in China. Patients satisfying the inclusion criteria will be randomly divided into 3 groups according to a 1:1:1 ratio, intervention group A (IGA), intervention group B (IGB) and control group (CG). Each group will receive adjuvant platinum-based doublet chemotherapy for a total of 4 cycles. IGA participants will receive chemotherapy combined with CHM and LZJ exercises, IGB participants will receive chemotherapy combined with CHM and rehabilitation education, and CG participants will receive chemotherapy combined with placebo and rehabilitation education. The herbal treatment patients will be given granules daily and LZJ exercises will be performed 4 times a week during chemotherapy. The primary outcome is QoL, which will be assessed with the EORTC (The European Organization for Research and Treatment of Cancer)-QLQ-C43 scale each cycle. The secondary outcomes include the 2-year disease-free survival rate, disease-free survival (DFS), TCM symptoms, tumor markers, safety and adverse events. After treatment, the patients will be followed up every 3 months within 2 years and every 6 months after 2 years until disease recurrence and/or metastasis. Discussion: Our previous study reported that CHM in combination with chemotherapy could lower the overall incidence of adverse events but increased digestive and gastrointestinal (GI) side effects compared with chemotherapy alone in postoperative NSCLC patients. This study will lay a foundation for the effectiveness of chemotherapy with or without a comprehensive rehabilitation program for QoL in patients with postoperative NSCLC.
Figure 1
Figure 2
Figure 3
This is a list of supplementary files associated with this preprint. Click to download.
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