Back to resultsEffect of Jianpi Huatan Decoction on Advanced Colorectal Cancer
Primary Purpose
Colorectal Neoplasms
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Jianpi Huatan dispensing granule
Placebo granule
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring colorectal cancer, traditional Chinese medicine
Eligibility Criteria
Inclusion Criteria:
- Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria.
- TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
- Expected survival time is over 3 months.
- The age of 18 years old or more.
- According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
- Chemotherapy and/or targeted therapy are planned.
- Signed informed consent.
Exclusion Criteria:
- History of previous or combined malignancies except non-melanoma skin cancer, cervical cancer in situ, or bladder cancer (Tis and T1) received adequate treatment in the five years prior to screening.
- Combined with severe heart, liver, lung and kidney disease.
- Patients have intestinal obstruction can't take decoction and need intravenous high-energy nutrition. Patients have malabsorption syndrome or other disease affecting gastrointestinal absorption or have active peptic ulcer disease.
- Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia.
- The expected survival time is less than 3 months.
- The researchers determine that they were not suitable for the study.
Sites / Locations
- Xiyuan Hospital of China Academy of Chinese Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Group
Control Group
Arm Description
The experimental group will take Jianpi Huatan dispensing granule while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
The experimental group will take Placebo granule (containing 1/10 of the formula dose of Jianpi Huatan Granule) while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Outcomes
Primary Outcome Measures
Progression-free survival
From enrollment until disease progression or death
Overall survival
From enrollment until death or end of the follow-up
Secondary Outcome Measures
Survival rate
The 1-year, 2-year and 3-year survival rates of patients in the treatment group and the control group were analyzed
Disease control rate
Efficacy was assessed according to RECIST 1.1 at the end of 3 months of treatment.
Cancer fatigue score
Piper Fatigue Scale will be used.The fatigue of patients will be evaluated from 22 items of behavioral dimension, emotional dimension, sensory dimension and cognitive dimension. The higher the score of each dimension, the more serious the fatigue degree.
Traditional Chinese Medicine(TCM )symptom grading table
Effective: after treatment, TCM symptom score decreased by more than 50% compared with that before treatment.
Effective: decrease < 50% and equal to 30%; Invalid: decrease < 30%. Note: the formula is: (before treatment - integral after treatment) / before treatment by 100%.
The European Organization for Cancer Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) score scale
The raw scores for the scales and single items were linearly transformed to values between 0 and 100 as described in the EORTC QLQ scoring manual. The mean and standard deviation of each scale/single item were calculated. A higher score for a functioning scale represented a healthier level of functioning, a higher score for the global health status scale represented a higher QOL, and a higher score for a symptom scale/item represented a worse level of symptomatology.
the United States Eastern Oncology Collaboration Group (ECOG) score scale
ECOG scoring standard is an indicator of patients' general health status and tolerance to treatment based on their physical strength. ECOG physical condition rating standard score 0-5 points. A minimum score of 0 indicates normal activity, a higher score indicates less physical activity, and a score of 5 indicates death.
Full Information
NCT ID
NCT05187481
First Posted
December 20, 2021
Last Updated
January 8, 2022
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
China Academy of Chinese Medical Sciences, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05187481
Brief Title
Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer
Official Title
Efficacy Evaluation of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer and Analysis of Dominant Population Characteristics and Methylation Characteristics
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
China Academy of Chinese Medical Sciences, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will take progression-free survival and overall survival as the main evaluation indexes, to evaluate the Efficacy of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer. Decision Trees and Discriminant Analysis will be used to analyze the characteristics of dominant population combined with clinical data of patients. DNA methylation of the subjects will be detected to study the methylation characteristics of the preponderant population of Jianpi Huatan Decoction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
colorectal cancer, traditional Chinese medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The experimental group will take Jianpi Huatan dispensing granule while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The experimental group will take Placebo granule (containing 1/10 of the formula dose of Jianpi Huatan Granule) while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Intervention Type
Drug
Intervention Name(s)
Jianpi Huatan dispensing granule
Intervention Description
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Intervention Type
Drug
Intervention Name(s)
Placebo granule
Intervention Description
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
From enrollment until disease progression or death
Time Frame
From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 100 months
Title
Overall survival
Description
From enrollment until death or end of the follow-up
Time Frame
From date of randomization until the date of death from any cause, assessed up to 100 months
Secondary Outcome Measure Information:
Title
Survival rate
Description
The 1-year, 2-year and 3-year survival rates of patients in the treatment group and the control group were analyzed
Time Frame
3 years
Title
Disease control rate
Description
Efficacy was assessed according to RECIST 1.1 at the end of 3 months of treatment.
Time Frame
3 months
Title
Cancer fatigue score
Description
Piper Fatigue Scale will be used.The fatigue of patients will be evaluated from 22 items of behavioral dimension, emotional dimension, sensory dimension and cognitive dimension. The higher the score of each dimension, the more serious the fatigue degree.
Time Frame
3 months
Title
Traditional Chinese Medicine(TCM )symptom grading table
Description
Effective: after treatment, TCM symptom score decreased by more than 50% compared with that before treatment.
Effective: decrease < 50% and equal to 30%; Invalid: decrease < 30%. Note: the formula is: (before treatment - integral after treatment) / before treatment by 100%.
Time Frame
3 months
Title
The European Organization for Cancer Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) score scale
Description
The raw scores for the scales and single items were linearly transformed to values between 0 and 100 as described in the EORTC QLQ scoring manual. The mean and standard deviation of each scale/single item were calculated. A higher score for a functioning scale represented a healthier level of functioning, a higher score for the global health status scale represented a higher QOL, and a higher score for a symptom scale/item represented a worse level of symptomatology.
Time Frame
3 months
Title
the United States Eastern Oncology Collaboration Group (ECOG) score scale
Description
ECOG scoring standard is an indicator of patients' general health status and tolerance to treatment based on their physical strength. ECOG physical condition rating standard score 0-5 points. A minimum score of 0 indicates normal activity, a higher score indicates less physical activity, and a score of 5 indicates death.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria.
TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
Expected survival time is over 3 months.
The age of 18 years old or more.
According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
Chemotherapy and/or targeted therapy are planned.
Signed informed consent.
Exclusion Criteria:
History of previous or combined malignancies except non-melanoma skin cancer, cervical cancer in situ, or bladder cancer (Tis and T1) received adequate treatment in the five years prior to screening.
Combined with severe heart, liver, lung and kidney disease.
Patients have intestinal obstruction can't take decoction and need intravenous high-energy nutrition. Patients have malabsorption syndrome or other disease affecting gastrointestinal absorption or have active peptic ulcer disease.
Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia.
The expected survival time is less than 3 months.
The researchers determine that they were not suitable for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wu, Master
Phone
010-62835438
Email
zoujianhua2021@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianhua Zou, Doctor
Phone
18810209092
Email
490943558@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Wu, Master
Organizational Affiliation
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Xiyuan Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cui Ning, master
Phone
15652590697
Email
809918686@qq.com
First Name & Middle Initial & Last Name & Degree
Jianhua Zou, Doctor
Phone
18810209092
Email
490943558@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer
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