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Trial record 37 of 1013 for:    colon cancer AND resection

Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03716063
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborators:
Chinese Academy of Medical Sciences
Tianjin People's Hospital
Information provided by (Responsible Party):
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Tracking Information
First Submitted Date  ICMJE October 8, 2018
First Posted Date  ICMJE October 23, 2018
Last Update Posted Date October 23, 2018
Estimated Study Start Date  ICMJE October 30, 2018
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
  • Disease-free survival time [ Time Frame: 3 years ]
    from the date of radical resection of colorectal cancer to the time of recurrence or metastasis.
  • Metastasis recurrence rate in 1 year [ Time Frame: 1 year ]
    The ratio of metastasis and recurrence to the patients was observed.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
  • Traditional Chinese Medicine(TCM )symptom grading table [ Time Frame: 3 months ]
    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 [ Time Frame: 3 months ]
    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 ) [ Time Frame: 3months ]
    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 [ Time Frame: 2 years ]
    The ratio of metastasis and recurrence to the patients was observed.
  • Metastasis recurrence rate in 3 years [ Time Frame: 3 years ]
    The ratio of metastasis and recurrence to the patients was observed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer
Official Title  ICMJE Evaluation and Mechanism of Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Care 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.
Primary Purpose: Prevention
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: Jianpi Huatan dispensing granule
once a day in the morning and evening, every month for a course of treatment, a total of three courses
Study Arms  ICMJE
  • Experimental: test group
    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.
    Intervention: Drug: Jianpi Huatan dispensing granule
  • Placebo Comparator: control group
    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: Drug: Jianpi Huatan dispensing granule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2018)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria;
  2. 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;
  3. Tumor Node Metastasis(TNM) stage is high-risk II stage and III stage;
  4. Age 18-80 years, sex unlimited;
  5. No recurrence or metastasis by imaging or doctor's clinical judgement;
  6. 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:

  1. History of previous or combined malignancies except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
  2. Combined with severe heart, liver and kidney disease;
  3. 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;
  4. The researchers determine that they were not suitable for the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: yu wu, master 010-62835438 18813084816@163.com
Contact: liusheng li, doctor 18811506082 719089886@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03716063
Other Study ID Numbers  ICMJE httxixi
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Xiyuan Hospital of China Academy of Chinese Medical Sciences
Study Sponsor  ICMJE Xiyuan Hospital of China Academy of Chinese Medical Sciences
Collaborators  ICMJE
  • Chinese Academy of Medical Sciences
  • Tianjin People's Hospital
Investigators  ICMJE
Study Chair: yufei yang, doctor Xiyuan Hospital of China Academy of Chinese Medical Sciences
PRS Account Xiyuan Hospital of China Academy of Chinese Medical Sciences
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP