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Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study

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Abstract

Background

Colorectal cancer (CRC) is the second most common cause of cancer-related deaths and has the third highest incidence in the world. Almost half of the patients with CRC have metastases at the time of diagnosis. However, the treatment for patients with metastatic CRC that progresses after approved conventional chemotherapy is still controversial. Chinese medicine (CM) has unique characteristics and advantages in treating metastatic CRC.

Objective

To assess the effectiveness and safety of CM in patients with metastatic CRC after failure of conventional chemotherapy.

Methods

The study is a multicenter prospective cohort study. A total of 384 patients with documented metastatic CRC after failure of conventional chemotherapy will be included from 9 hospitals among Beijing, Shanghai, Nanjing, and Guizhou, and assigned to three groups according to paitents’ wishes: (1) integrated Chinese and Western medicine (ICM) group receiving CM herbal treatment combined with Western medicine (WM) anti-tumor therapy, (2) Chinese medicine (CM) group receiving only CM herbal treatment, and (3) WM group receiving only WM anti-tumor therapy. The primary endpoint is the overall survival (OS). Secondary endpoints include the progression free survival (PFS), quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire, tumor control, and CM symptom score.

Discussion

This prospective study will assess the effectiveness and safety of CM in treating metastatic CRC after conventional chemotherapy failure. Patients in the ICM group will be compared with those in the WM group and CM group. If certified to be effective, national provision of CM treatment in metastatic CRC will probably be advised. (Registration No. NCT02923622 on ClinicalTrials.gov)

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Acknowledgements

We would like to acknowledge QIU Pan-bo from the Institute of Clinical Pharmacology, Xiyuan Hospital of the China Academy of Chinese Medical Sciences for electronic data management. We would like to thank the Integrated Traditional Chinese and Western Medicine, Beijing Cancer Hospital, Guang’anmen Hospital of the China Academy of Chinese Medical Sciences, Beijing Hospital of Chinese Medicine Affiliated to Capital Medical University, Cancer Hospital of the Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Longhua hospital of Shanghai University of Traditional Chinese Medicine, The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, and Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine for cases collection.

Author information

Authors and Affiliations

  1. Department of Oncology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China

    Teng-teng Hao, Yun Xu, Ning Cui, Qian Qu & Yu Wu

  2. Chinese Mdeicine Center for AIDS Prevention and Treatment, China Academy of Chinese Medical Sciences, Beijing, 100700, China

    Bi-yan Liang

  3. Department of Oncology, Beijing Hospital of Integrated Traditional Chinese and Western Medicine, Beijing, 100039, China

    Ju-hua Yuan

  4. Institute of Clinical Pharmacology, Xiyuan Hospital, China Academy of Chinese Medicine Sciences, Beijing, 100091, China

    Yang Zhao, Qing-na Li & Fang Lu

Authors
  1. Teng-teng Hao
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  2. Yun Xu
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  3. Ning Cui
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  4. Qian Qu
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  5. Bi-yan Liang
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  7. Yang Zhao
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  8. Qing-na Li
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  9. Fang Lu
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  10. Yu Wu
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Contributions

Wu Y initiated the project and was a major contributor in writing the protocol. Xu Y contributed to the study design and revising the protocol. Hao TT is a major contributor in writing the protocol and implementing the study design. Cui N, Qu Q, Yuan JH, Liang BY, Zhao Y, Li QN, and Lu F were involved in the study design by attending several investigators’ meetings in which the protocol and CRF were adjusted to the current protocol. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Yu Wu.

Ethics declarations

The authors declare that they have no competing interests. The funding body did not have any role in the design of the study, data collection, or in writing the manuscript.

Additional information

Supported by the Beijing Municipal Commission of Science and Technology (No. D161100005116002)

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11655_2020_3420_MOESM1_ESM.pdf

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Hao, Tt., Xu, Y., Cui, N. et al. Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study. Chin. J. Integr. Med. 27, 674–679 (2021). https://doi.org/10.1007/s11655-020-3420-0

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  • DOI: https://doi.org/10.1007/s11655-020-3420-0

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