Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer

January 8, 2022 updated by: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Efficacy Evaluation of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer and Analysis of Dominant Population Characteristics and Methylation Characteristics

This study will take progression-free survival and overall survival as the main evaluation indexes, to evaluate the Efficacy of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer. Decision Trees and Discriminant Analysis will be used to analyze the characteristics of dominant population combined with clinical data of patients. DNA methylation of the subjects will be detected to study the methylation characteristics of the preponderant population of Jianpi Huatan Decoction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xiyuan Hospital of China Academy of Chinese Medical Sciences
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (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. TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
  3. Expected survival time is over 3 months.
  4. The age of 18 years old or more.
  5. According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
  6. Chemotherapy and/or targeted therapy are planned.
  7. Signed informed consent.

Exclusion Criteria:

  1. History of previous or combined malignancies except non-melanoma skin cancer, cervical cancer in situ, or bladder cancer (Tis and T1) received adequate treatment in the five years prior to screening.
  2. Combined with severe heart, liver, lung and kidney disease.
  3. Patients have intestinal obstruction can't take decoction and need intravenous high-energy nutrition. Patients have malabsorption syndrome or other disease affecting gastrointestinal absorption or have active peptic ulcer disease.
  4. 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.
  5. The expected survival time is less than 3 months.
  6. The researchers determine that they were not suitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
The experimental group will take Jianpi Huatan dispensing granule while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Drug: Jianpi Huatan dispensing granule
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Placebo Comparator: Control Group
The experimental group will take Placebo granule (containing 1/10 of the formula dose of Jianpi Huatan Granule) while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
Drug: Placebo granule
once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 100 months
From enrollment until disease progression or death
From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 100 months
From enrollment until death or end of the follow-up
From date of randomization until the date of death from any cause, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 3 years
The 1-year, 2-year and 3-year survival rates of patients in the treatment group and the control group were analyzed
3 years
Disease control rate
Time Frame: 3 months
Efficacy was assessed according to RECIST 1.1 at the end of 3 months of treatment.
3 months
Cancer fatigue score
Time Frame: 3 months
Piper Fatigue Scale will be used.The fatigue of patients will be evaluated from 22 items of behavioral dimension, emotional dimension, sensory dimension and cognitive dimension. The higher the score of each dimension, the more serious the fatigue degree.
3 months
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%.
3 months
The European Organization for Cancer Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) score scale
Time Frame: 3 months
The raw scores for the scales and single items were linearly transformed to values between 0 and 100 as described in the EORTC QLQ scoring manual. The mean and standard deviation of each scale/single item were calculated. A higher score for a functioning scale represented a healthier level of functioning, a higher score for the global health status scale represented a higher QOL, and a higher score for a symptom scale/item represented a worse level of symptomatology.
3 months
the United States Eastern Oncology Collaboration Group (ECOG) score scale
Time Frame: 3 months
ECOG scoring standard is an indicator of patients' general health status and tolerance to treatment based on their physical strength. ECOG physical condition rating standard score 0-5 points. A minimum score of 0 indicates normal activity, a higher score indicates less physical activity, and a score of 5 indicates death.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Collaborators

Guang'anmen Hospital of China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences

Investigators

  • Study Chair: Yu Wu, Master, Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

January 8, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 8, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI2021A01803

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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