Clinical trial NCT03716063: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Keywords: colorectal cancer
traditional Chinese medicine
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
name: Tianjin People's Hospital
First posted: 2018-10-23
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Disease-free survival time
timeFrame: 3 years
measure: Metastasis recurrence rate in 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Traditional Chinese Medicine(TCM )symptom grading table
timeFrame: 3 months
measure: Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale
timeFrame: 3 months
measure: Edmonton Symptom Assessment Scale( ESAS )
timeFrame: 3months
measure: Metastasis recurrence rate in 2 years
timeFrame: 2 years
measure: Metastasis recurrence rate in 3 years
timeFrame: 3 years
Other outcomes:
Locations:
city: Peking
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: yufei yang, doctor
role: STUDY_CHAIR
References:
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.