Study Results
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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UNKNOWN
PHASE3
400 participants
INTERVENTIONAL
2018-12-12
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TCM group
Tonifying Spleen and Kidney Sequential Regimen(TSKSR) will be prescribed to the participants in each course of chemotherapy.
Tonifying Spleen and Kidney Sequential Regimen
TSKSR will be given to the participants as follows:Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and Qi-tu-er-zhi Granule,1 pack each time,twice a day,PO,from 7th to 20th day of chemotherapy.
Placebo group
Placebo of Tonifying Spleen and Kidney Sequential Regimen(TSKSR)similar in color,smell and texture with TSKSR will be prescribed to participants in each course of chemotherapy.
Placebo of 'Tonifying Spleen and Kidney Sequential Regimen
Placebo of TCM-TSKSR will be given to the participants as follows:placebo of Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and placebo of Qi-tu-er-zhi Granule,1 pack each time,twice a day,from 7th to 20th day of chemotherapy.
Interventions
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Tonifying Spleen and Kidney Sequential Regimen
TSKSR will be given to the participants as follows:Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and Qi-tu-er-zhi Granule,1 pack each time,twice a day,PO,from 7th to 20th day of chemotherapy.
Placebo of 'Tonifying Spleen and Kidney Sequential Regimen
Placebo of TCM-TSKSR will be given to the participants as follows:placebo of Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and placebo of Qi-tu-er-zhi Granule,1 pack each time,twice a day,from 7th to 20th day of chemotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* tumor-node-metastasis(TNM)Stage II (high-risk)or III colon cancer according to 8th edition of American Joint Committee on Cancer(AJCC)Staging Manual. High-risk stage II disease is characterized by at least one of the following:
1. T4 tumor,
2. inadequately sampled nodes (\<12 lymph nodes),
3. clinical presentation with bowel obstruction or perforation,
4. poorly differentiated histology ,exclusive of those cancers that are High degree of microsatellite instability(MSI-H),
5. lymphovascular invasion,perineural invasion(PNI).
* Underwent radical surgery no more than six weeks ago and plan to start chemotherapy.
* Have not been enrolled in other therapeutic clinical trials within the near 30 days.
* Age between 18 to 75 years; All genders; Eastern Cooperative Oncology Group - performance status(ECOG-PS)from 0 to 2; Women who are pregnant, lactating or of reproductive age are not eligible, while those of reproductive age using secure contraceptives are eligible.
* No history of previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 5 years.
* Laboratory testing: blood routine examination: WBC≥3.5×109/L，NEUT≥1.5×109/L,PLT≥100×109/L,HGB≥90g/L;biochemical tests:TBIL≤1.5×ULN,AST(SGOT),ALT(SGPT)≤2.5×ULN,Scr≤1.5×ULN;CEA after surgery was normal.
* Consented.
* Agree not to be enrolled in other interventional studies during the research.
Exclusion Criteria
* Clinically relevant cardiovascular and/or cerebrovascular disease,active hepatitis,severe abnormalities in liver/ renal function tests.
* Known allergy to any of the components of study drug.
* Those who cannot take the study drug orally because of bowel obstruction and/or require for peripheral vein nutrition.
* Malabsorption or diseases that affect the absorption.
* Unstable situations or situations that may endanger the safety of patients and their compliance, such as severe mental illness,schizophrenia.
* Colostomy
18 Years
75 Years
ALL
No
Sponsors
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Beijing University of Chinese Medicine
OTHER
Peking University Third Hospital
OTHER
Beijing Chao Yang Hospital
OTHER
Jiangsu Province Hospital of Traditional Chinese Medicine
OTHER
Shanghai Zhongshan Hospital
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Tianjin Union Medical Center
OTHER
Henan Provincial People's Hospital
OTHER
Zhengzhou Hospital of Traditional Chinese Medicine
OTHER
Peking University Cancer Hospital & Institute
OTHER
Chongqing University Cancer Hospital
OTHER
Civil Aviation General Hospital
OTHER
Xiyuan Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Yufei Yang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
Locations
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Beijing Chao Yang Hospital
Beijing, Beijing Municipality, China
Civil Aviation General Hospital
Beijing, Beijing Municipality, China
Oncology Department of Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangdong, Guangzhou, China
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Zhengzhou Hospital of Traditional Chinese Medicine
Zhengzhou, Henan, China
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Tianjin Union Medical Center
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Minzhe Li, M.D.
Role: primary
Jianping Cheng
Role: primary
Aiwen Wu, M.D.
Role: primary
Wei Wang
Role: primary
Jin Wan, M.D.
Role: primary
Yang Cao
Role: primary
Shundong Cang, M.D.
Role: primary
Baozhu Zeng
Role: primary
Peng Shu, M.D.
Role: primary
Tianshu Liu, M.D.
Role: primary
Huaqing Wang, M.D.
Role: primary
References
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Zhang T, Fei YT, Xu Y, Sun LY, He B, Yan SH, Tang M, Yan YZ, Mao J, Yang YF. Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial. Chin J Integr Med. 2021 Dec;27(12):891-895. doi: 10.1007/s11655-021-3448-9. Epub 2021 Aug 25.
Other Identifiers
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2017YFC1700604
Identifier Type: -
Identifier Source: org_study_id
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