Back to resultsStrengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Jianpi Huatan dispensing granule
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer 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；
- Radical resection of colorectal cancer was performed and adjuvant chemotherapy (based on 5-FU regimens for at least 3 months) was completed within 3 months of the end of chemotherapy；
- Tumor Node Metastasis(TNM) stage is high-risk II stage and III stage；
- Age 18-80 years, sex unlimited；
- No recurrence or metastasis by imaging or doctor's clinical judgement；
- Signed informed consent； Note * According to National Comprehensive Cancer Network(NCCN )clinical guidelines: Phase II:T3-4N0M0; High-risk Phase II is defined as follows:：a.T4;b. Less than 12 lymph nodes were detected；c. preoperative intestinal obstruction, perforation of tumor site；d. poor histological differentiation (except highly unstable microsatellite)；e. neurological invasion and vascular tumor thrombus； f. positive or unknown margin, and insufficient margin safety distance. Phase III：T1-4N1-2M0.
Exclusion criteria:
- History of previous or combined malignancies except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix；
- Combined with severe heart, liver and kidney 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 researchers determine that they were not suitable for the study.
Sites / Locations
- Xiyuan Hospital, China Academy of Chinese Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
test group
control group
Arm Description
The test group will oral Jianpi Huatan dispensing granule , once a day in the morning and evening, once a month for a course of treatment, a total of three courses.
The control group will oral drug:low-dose control granules (containing 1/10 of the dose of the experimental group) , once a day in the morning and evening, once a month for a course of treatment, a total of three courses
Outcomes
Primary Outcome Measures
Disease-free survival time
from the date of radical resection of colorectal cancer to the time of recurrence or metastasis.
Metastasis recurrence rate in 1 year
The ratio of metastasis and recurrence to the patients was observed.
Secondary Outcome Measures
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%
Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale
The FACT-C scale was divided into five grades: none (0), one point (1), some (2), equivalent (3) and very (4). The positive items (i.e. the higher the grade, the better the quality of life.)
Edmonton Symptom Assessment Scale( ESAS )
The scale used digital scoring method, each symptom scoring range of 0-10 points, 0 points for asymptomatic, 10 points for the most serious degree imaginable, patients choose a number to express their subjective feelings, the larger the number indicates the more serious the symptoms. 1~10 points were divided into 3 degrees, mild, moderate and severe. 1~3 were mild, 4~6 were moderate, and 7~10 were severe
Metastasis recurrence rate in 2 years
The ratio of metastasis and recurrence to the patients was observed.
Metastasis recurrence rate in 3 years
The ratio of metastasis and recurrence to the patients was observed.
Full Information
NCT ID
NCT03716063
First Posted
October 8, 2018
Last Updated
October 22, 2018
Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
Chinese Academy of Medical Sciences, Tianjin People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03716063
Brief Title
Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer
Official Title
Evaluation and Mechanism of Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2018 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators
Chinese Academy of Medical Sciences, Tianjin People's Hospital
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 disease-free survival time and recurrence and metastasis rate as the main evaluation indexes, to evaluate the clinical efficacy of strengthening the spleen and reducing phlegm method in patients with stage II high-risk and stage III colorectal cancer
Detailed Description
The study enrolled 350 patients with stage II high-risk and stage III colorectal cancer who underwent adjuvant chemotherapy (based on a 5-fluorouracil（5-FU） regimen for at least 3 months) and patients who received chemotherapy for less than 3 months. The study will use a large sample, multicenter, randomized, double-blind study. The experimental group was given oral Jianpi Huatan dispensing granule, once a day in the morning and evening, 1 course per 1 month, a total of 3 courses; the control group of oral Chinese medicine formula low dose control granules (including the test group dose 1 /10), 1 time each morning and evening, 1 course per month, for a total of 3 courses.
The patients were followed up once a month during the treatment period and once every 3-6 months after the end of treatment until the patient relapsed, died or the study was over.Some patients in the study will be tested for circulating tumor cells.
Main outcome measures is Disease-free survival time（DFS）and Metastasis recurrence rate in 1 year；Secondary outcome measures：Quality of life score: applied quality of life scale.Metastasis recurrence rate in 2、3years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, traditional Chinese medicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This study was double-blind. According to the randomized results, the experimental group was given orally therapeutic granules, while the control group was given orally low-dose granules.
Masking
ParticipantCare Provider
Masking Description
This study was double-blind. According to the randomized results, the experimental group was given orally therapeutic granules, while the control group was given orally low-dose granules. Random sequence was generated by professional statisticians of group leader unit by statistical software. 350 subjects were divided into experimental group and control group according to the ratio of 1:1, 175 cases in each group. Random seeds and random sequences are stored as confidential data in opaque envelopes, and emergency envelopes are handed over to a third party to ensure that patients, researchers and outcome evaluators are unaware of the patient group before blindness is uncovered. After successful screening and signing the informed consent form, the patient can open a random envelope in turn and record the subject's name, hospital number and admission time on the envelope.
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
test group
Arm Type
Experimental
Arm Description
The test group will oral Jianpi Huatan dispensing granule , once a day in the morning and evening, once a month for a course of treatment, a total of three courses.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The control group will oral drug:low-dose control granules (containing 1/10 of the dose of the experimental group) , once a day in the morning and evening, once a month for a course of treatment, a total of three courses
Intervention Type
Drug
Intervention Name(s)
Jianpi Huatan dispensing granule
Intervention Description
once a day in the morning and evening, every month for a course of treatment, a total of three courses
Primary Outcome Measure Information:
Title
Disease-free survival time
Description
from the date of radical resection of colorectal cancer to the time of recurrence or metastasis.
Time Frame
3 years
Title
Metastasis recurrence rate in 1 year
Description
The ratio of metastasis and recurrence to the patients was observed.
Time Frame
1 year
Secondary Outcome Measure Information:
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
Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale
Description
The FACT-C scale was divided into five grades: none (0), one point (1), some (2), equivalent (3) and very (4). The positive items (i.e. the higher the grade, the better the quality of life.)
Time Frame
3 months
Title
Edmonton Symptom Assessment Scale( ESAS )
Description
The scale used digital scoring method, each symptom scoring range of 0-10 points, 0 points for asymptomatic, 10 points for the most serious degree imaginable, patients choose a number to express their subjective feelings, the larger the number indicates the more serious the symptoms. 1~10 points were divided into 3 degrees, mild, moderate and severe. 1~3 were mild, 4~6 were moderate, and 7~10 were severe
Time Frame
3months
Title
Metastasis recurrence rate in 2 years
Description
The ratio of metastasis and recurrence to the patients was observed.
Time Frame
2 years
Title
Metastasis recurrence rate in 3 years
Description
The ratio of metastasis and recurrence to the patients was observed.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria；
Radical resection of colorectal cancer was performed and adjuvant chemotherapy (based on 5-FU regimens for at least 3 months) was completed within 3 months of the end of chemotherapy；
Tumor Node Metastasis(TNM) stage is high-risk II stage and III stage；
Age 18-80 years, sex unlimited；
No recurrence or metastasis by imaging or doctor's clinical judgement；
Signed informed consent； Note * According to National Comprehensive Cancer Network(NCCN )clinical guidelines: Phase II:T3-4N0M0; High-risk Phase II is defined as follows:：a.T4;b. Less than 12 lymph nodes were detected；c. preoperative intestinal obstruction, perforation of tumor site；d. poor histological differentiation (except highly unstable microsatellite)；e. neurological invasion and vascular tumor thrombus； f. positive or unknown margin, and insufficient margin safety distance. Phase III：T1-4N1-2M0.
Exclusion criteria:
History of previous or combined malignancies except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix；
Combined with severe heart, liver and kidney 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 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
18813084816@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
liusheng li, doctor
Phone
18811506082
Email
719089886@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yufei yang, doctor
Organizational Affiliation
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Xiyuan Hospital, China Academy of Chinese Medical Sciences
City
Peking
State/Province
Beijing
ZIP/Postal Code
100091
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
liusheng li, doctor
Phone
18811506082
Email
719089886@qq.com
First Name & Middle Initial & Last Name & Degree
ning cui, master
Phone
15652590697
Email
809918686@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36176445
Citation
Li L, Qu Q, Cui N, Cai L, Zou J, Wu J, Hao T, Wu Y. Efficacy of jianpi huatan granule in reducing colorectal cancer metastasis and recurrence after radical resection and adjuvant chemotherapy: Study protocol for a randomised, double-blind, placebo-controlled, multicentre trial. Front Pharmacol. 2022 Sep 13;13:944475. doi: 10.3389/fphar.2022.944475. eCollection 2022.
Results Reference
derived
Learn more about this trial
Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer
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