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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03716063
• Other study ID #: httxixi
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 30, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2018
• Source: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Contact: yu wu, master
• Phone: 010-62835438
• Email: 18813084816[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Xiyuan Hospital, China Academy of Chinese Medical Sciences	Peking	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Xiyuan Hospital of China Academy of Chinese Medical Sciences	Chinese Academy of Medical Sciences, Tianjin People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival time	from the date of radical resection of colorectal cancer to the time of recurrence or metastasis.	3 years
Primary	Metastasis recurrence rate in 1 year	The ratio of metastasis and recurrence to the patients was observed.	1 year
Secondary	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%	3 months
Secondary	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.)	3 months
Secondary	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	3months
Secondary	Metastasis recurrence rate in 2 years	The ratio of metastasis and recurrence to the patients was observed.	2 years
Secondary	Metastasis recurrence rate in 3 years	The ratio of metastasis and recurrence to the patients was observed.	3 years