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

NCT03716063 | Unknown Phase 3

• 1 other identifier: httxixi
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Cancer

Keywords

colorectal cancer; traditional Chinese medicine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Traditional Chinese Medicine(TCM )symptom grading table

  3 months

• Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale

  3 months

• Edmonton Symptom Assessment Scale( ESAS )

  3months

• Metastasis recurrence rate in 2 years

  2 years

• Metastasis recurrence rate in 3 years

  3 years

Study Arms (2)

test group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

Jianpi Huatan dispensing granule DRUG

once a day in the morning and evening, every month for a course of treatment, a total of three courses

control group; test group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of previous or combined malignancies except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix；
• Combined with severe heart, liver and kidney disease；
• 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;
• The researchers determine that they were not suitable for the study.

Sponsors & Collaborators

• Xiyuan Hospital of China Academy of Chinese Medical Sciences: lead
• Chinese Academy of Medical Sciences: collaborator
• Tianjin People's Hospital: collaborator

Study Sites (1)

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

Location

Related Publications (1)

• 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.

  PMID: 36176445 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• yufei yang, doctor

  Xiyuan Hospital of China Academy of Chinese Medical Sciences

  STUDY CHAIR

Central Study Contacts

yu wu, master

CONTACT

010-62835438; 18813084816@163.com

liusheng li, doctor

CONTACT

18811506082; 719089886@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 23, 2018
• Study Start: October 30, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

CN (1)