Efficacy and Safety Evaluation of Traditional Chinese Medicine in the Treatment of Advanced Colorectal Cancer

NCT ID: NCT02923622

Last Updated: 2016-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Brief Summary

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Although patients of colorectal cancer use Traditional Chinese Medicine (TCM) herbal therapy extensively in China, no strong evidence exists to demonstrate the safety and survival outcomes of TCM herbal therapy combined with conventional western medicine for treatment of this disease. The purpose of this multi-center perspective cohort study is to evaluate the relationship between TCM herbal therapy and survival outcomes in patients with advanced colorectal cancer.

Detailed Description

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Conditions

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Advanced Colorectal Cancer Traditional Chinese Medicine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Traditional Chinese and Western medicine combined group

Integrated traditional Chinese and Western medicine

Intervention Type OTHER

TCM herbal treatment combine with anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)

Traditional Chinese medicine group

Traditional Chinese medicine herbals

Intervention Type OTHER

TCM herbal treatment based on TCM syndrome differentiation,without any anti tumor therapy in Western Medicine

Western medicine group

Western medicine

Intervention Type OTHER

Anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)

Interventions

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Traditional Chinese medicine herbals

TCM herbal treatment based on TCM syndrome differentiation,without any anti tumor therapy in Western Medicine

Intervention Type OTHER

Integrated traditional Chinese and Western medicine

TCM herbal treatment combine with anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)

Intervention Type OTHER

Western medicine

Anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* histologically confirmed adenocarcinoma of the colon or rectum
* TNM classification of stage IV disease according to American Joint Committee on Cancer
* Between 18 and 80 years old
* Progression or inability undergone conventional chemotherapy (Conventional chemotherapy regimen containing fluorouracil, oxaliplatin, irinotecan based chemotherapy, and all the above regimen should be used before)
* Expected survival time is over 3 months
* Signed informed consent

Exclusion Criteria

* serious non-malignant diseases such as heart, renal, and hepatic illnesses
* the presence of other types of malignancies
* The patients can not take medicine for intestinal obstruction
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role collaborator

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oncology Department of Xiyuan hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Facility Contacts

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Yun Xu, M.D.

Role: primary

86 10 62835355

Yu Wu, M.D.

Role: backup

86 10 62835438

References

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Hao TT, Xu Y, Cui N, Qu Q, Liang BY, Yuan JH, Zhao Y, Li QN, Lu F, Wu Y. 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. 2021 Sep;27(9):674-679. doi: 10.1007/s11655-020-3420-0. Epub 2020 Aug 19.

Reference Type DERIVED
PMID: 32820453 (View on PubMed)

Other Identifiers

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D161100005116002

Identifier Type: -

Identifier Source: org_study_id

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