NCT03716518

Brief Summary

This study is designed to:(1) determine the efficacy of Traditional Chinese Medicine (TCM) 'Tonifying Spleen and Kidney Sequential Regimen' (TSKSR) in improving the completion rate of 8-cycle CapeOX chemotherapy in patients with stage II (high-risk)\& III colon cancer;(2) evaluate the efficacy of the TCM-TSKSR on adverse events of CapeOX chemotherapy and it's impact on patients' quality of life (QoL).A randomized,double-blinded,placebo-controlled clinical trial including seven centers will be conducted in Mainland China.The study will enroll patients with stage II (high-risk)\& III colon cancer who have completed radical surgery and are going to receive CapeOX chemotherapy.All participants will receive chemotherapy as prescribed by their treating physicians and be randomly assigned to either concurrent use of TCM-TSKSR or placebo.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 12, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

January 12, 2021

Status Verified

November 1, 2020

Enrollment Period

2.5 years

First QC Date

October 14, 2018

Last Update Submit

January 9, 2021

Conditions

Colon Cancer

Keywords

Colon CancerTraditional Chinese MedicineAdverse Effect of ChemotherapyChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Completion Rate of 8-cycle Adjuvant Chemotherapy

    Completion Rate of 8-cycle Adjuvant Chemotherapy=number of participants completing 8-cycle adjuvant chemotherapy/number of participants randomized to each group\*100%

    6months

Secondary Outcomes (17)

  • Completion Rate of Adjuvant Chemotherapy of Each Participant

    6months

  • Completion Rate of 4-cycle Adjuvant Chemotherapy

    3months

  • Time to Treatment Failure,TTF

    6months

  • Relative Dose Intensity (RDI) of Adjuvant Chemotherapy

    6months

  • Proportion of Modifications of Time

    6months

  • +12 more secondary outcomes

Study Arms (2)

TCM group

EXPERIMENTAL

Tonifying Spleen and Kidney Sequential Regimen(TSKSR) will be prescribed to the participants in each course of chemotherapy.

Drug: Tonifying Spleen and Kidney Sequential Regimen

Placebo group

PLACEBO COMPARATOR

Placebo of Tonifying Spleen and Kidney Sequential Regimen(TSKSR)similar in color,smell and texture with TSKSR will be prescribed to participants in each course of chemotherapy.

Drug: Placebo of 'Tonifying Spleen and Kidney Sequential Regimen

Interventions

Tonifying Spleen and Kidney Sequential RegimenDRUG

TSKSR will be given to the participants as follows:Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and Qi-tu-er-zhi Granule,1 pack each time,twice a day,PO,from 7th to 20th day of chemotherapy.

Also known as: TSKSR
TCM group
Placebo of 'Tonifying Spleen and Kidney Sequential RegimenDRUG

Placebo of TCM-TSKSR will be given to the participants as follows:placebo of Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and placebo of Qi-tu-er-zhi Granule,1 pack each time,twice a day,from 7th to 20th day of chemotherapy.

Also known as: Placebo of TSKSR
Placebo group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with pathological diagnosis of colon cancer; no residual tumor at the resection margin.
  • tumor-node-metastasis(TNM)Stage II (high-risk)or III colon cancer according to 8th edition of American Joint Committee on Cancer(AJCC)Staging Manual. High-risk stage II disease is characterized by at least one of the following:
  • T4 tumor,
  • inadequately sampled nodes (\<12 lymph nodes),
  • clinical presentation with bowel obstruction or perforation,
  • poorly differentiated histology ,exclusive of those cancers that are High degree of microsatellite instability(MSI-H),
  • lymphovascular invasion,perineural invasion(PNI).
  • Underwent radical surgery no more than six weeks ago and plan to start chemotherapy.
  • Have not been enrolled in other therapeutic clinical trials within the near 30 days.
  • Age between 18 to 75 years; All genders; Eastern Cooperative Oncology Group - performance status(ECOG-PS)from 0 to 2; Women who are pregnant, lactating or of reproductive age are not eligible, while those of reproductive age using secure contraceptives are eligible.
  • No history of previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 5 years.
  • Laboratory testing: blood routine examination: WBC≥3.5×109/L，NEUT≥1.5×109/L,PLT≥100×109/L,HGB≥90g/L;biochemical tests:TBIL≤1.5×ULN,AST(SGOT),ALT(SGPT)≤2.5×ULN,Scr≤1.5×ULN;CEA after surgery was normal.
  • Consented.
  • Agree not to be enrolled in other interventional studies during the research.

You may not qualify if:

  • Patients not suitable for chemotherapy of CapeOX ,which will be determined by the investigator or the attending physician.
  • Clinically relevant cardiovascular and/or cerebrovascular disease,active hepatitis,severe abnormalities in liver/ renal function tests.
  • Known allergy to any of the components of study drug.
  • Those who cannot take the study drug orally because of bowel obstruction and/or require for peripheral vein nutrition.
  • Malabsorption or diseases that affect the absorption.
  • Unstable situations or situations that may endanger the safety of patients and their compliance, such as severe mental illness,schizophrenia.
  • Colostomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

Civil Aviation General Hospital

Beijing, Beijing Municipality, 100025, China

RECRUITING

Oncology Department of Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangdong, Guangzhou, 510120, China

RECRUITING

The Third People's Hospital of Zhengzhou

Zhengzhou, Henan, 450000, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Zhengzhou Hospital of Traditional Chinese Medicine

Zhengzhou, Henan, 450007, China

RECRUITING

Jiangsu Province Hospital of Traditional Chinese Medicine

Nanjing, Jiangsu, 210029, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Tianjin Union Medical Center

Tianjin, Tianjin Municipality, 300121, China

RECRUITING

Related Publications (1)

  • Zhang T, Fei YT, Xu Y, Sun LY, He B, Yan SH, Tang M, Yan YZ, Mao J, Yang YF. Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial. Chin J Integr Med. 2021 Dec;27(12):891-895. doi: 10.1007/s11655-021-3448-9. Epub 2021 Aug 25.

    PMID: 34432206DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Yufei Yang, M.D.

    Xi-Yuan Hospital, China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yufei Yang, M.D.

CONTACT

8613701366913yyfwdbwyy@126.com

Yun Xu, M.D.

CONTACT

8615210775378xyxiao78@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2018

First Posted

October 23, 2018

Study Start

December 12, 2018

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

January 12, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(12)