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

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

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Jianpi Huatan dispensing granule

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: Interventional
• Enrollment (Anticipated): 350
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: yu wu, master; Phone Number: 010-62835438; Email: 18813084816@163.com
• Study Contact Backup: Name: liusheng li, doctor; Phone Number: 18811506082; Email: 719089886@qq.com

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100091
      • Xiyuan Hospital, China Academy of Chinese Medical Sciences
      • Contact: liusheng li, doctor; Phone Number: 18811506082; Email: 719089886@qq.com
      • Contact: ning cui, master; Phone Number: 15652590697; Email: 809918686@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival time	from the date of radical resection of colorectal cancer to the time of recurrence or metastasis.	3 years
Metastasis recurrence rate in 1 year	The ratio of metastasis and recurrence to the patients was observed.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Metastasis recurrence rate in 2 years	The ratio of metastasis and recurrence to the patients was observed.	2 years
Metastasis recurrence rate in 3 years	The ratio of metastasis and recurrence to the patients was observed.	3 years

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Tianjin People's Hospital
• Investigators: Study Chair: yufei yang, doctor, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2018
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: colorectal cancer; traditional Chinese medicine
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: httxixi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No