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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
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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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Jianpi Huatan dispensing granule Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
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
Official Title: Evaluation and Mechanism of Strengthening the Spleen and Reducing Phlegm Method in Improving Radical Resection Rate of Colorectal Cancer
Estimated Study Start Date : October 30, 2018
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
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Arm Intervention/treatment
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.
 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
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival time [ Time Frame: 3 years ]
    from the date of radical resection of colorectal cancer to the time of recurrence or metastasis.

  2. Metastasis recurrence rate in 1 year [ Time Frame: 1 year ]
    The ratio of metastasis and recurrence to the patients was observed.


Secondary Outcome Measures :
  1. 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%


  2. 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.)

  3. 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

  4. Metastasis recurrence rate in 2 years [ Time Frame: 2 years ]
    The ratio of metastasis and recurrence to the patients was observed.

  5. Metastasis recurrence rate in 3 years [ Time Frame: 3 years ]
    The ratio of metastasis and recurrence to the patients was observed.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716063


Contacts
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Contact: yu wu, master 010-62835438 18813084816@163.com
Contact: liusheng li, doctor 18811506082 719089886@qq.com

Locations
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China, Beijing
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Peking, Beijing, China, 100091
Contact: liusheng li, doctor    18811506082    719089886@qq.com   
Contact: ning cui, master    15652590697    809918686@qq.com   
Sponsors and Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Chinese Academy of Medical Sciences
Tianjin People's Hospital
Investigators
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Study Chair: yufei yang, doctor Xiyuan Hospital of China Academy of Chinese Medical Sciences
More Information
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Responsible Party: Xiyuan Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03716063    
Other Study ID Numbers: httxixi
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiyuan Hospital of China Academy of Chinese Medical Sciences:
colorectal cancer
traditional Chinese medicine
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases