Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Colon Cancer

Official title

Efficacy of Xian-Lian-Jie-Du Optimization Decoction As an Adjuvant Treatment for Prevention of Recurrence of Stage IIIB/IIIC Colon Cancer：a Study Protocol for a Randomized Controlled Trial

Overview

This study is designed as a multi-center, randomized, double-blind, placebo-controlled trial. Subjects in the intervention group will be treated with XLJDOD compound granule. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent).

Detailed description

Subjects in the intervention group will be treated with XLJDOD compound granule. Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses. Subjects in the control group will be treated with placebo (XLJDOD mimetic agent). The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.

Interventions

• Drug XLJDOD compound granule
  Treatment will begin within 3 months after standard adjuvant chemotherapy and compliance will be continuously monitored. XLJDOD will be taken twice a day, infused with warm water, 1 hour after lunch and dinner. One course of treatment will take 28 days in 1 month, and 2- to 3-day rest. Treatment will continue for 6 courses.
• Drug placebo (XLJDOD mimetic agent)
  The course of placebo in control group will be in accordance with that of XLJDOD in intervention group.

Primary outcome measures

• Two-year disease-free survival (DFS) [Time frame: Assess once 24 months after randomization]

Secondary outcome measures (6)

• Three-year disease-free survival (DFS) [Time frame: Assess once 36 months after randomization]
• One, two, three-year relapse rate (RR) [Time frame: Assess at month 12, 24, 36 after randomization]
• Three-year survival rate [Time frame: Assess once 36 months after randomization]
• Overall survival (OS) [Time frame: Observation to the end of the study，assessed up to 24 months]
• Changes in total score on the EORTCQLQ-C30 Scale [Time frame: Measurement will be performed at baseline and month 6, 12 ,18 ,24, 36.]
• Changes in total score on the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM) [Time frame: Compared with the baseline period, the changes in MDASI-TCM score at month 6, 12 ,18 ,24, 36 will be measured.]

Eligibility criteria

Inclusion criteria

• Colon carcinoma confirmed by pathology.\*

\*Preoperative endoscopy showed that the distal end of the tumor was ≥12cm from the anal margin. If the patient did not undergo endoscopic examination before surgery, the distance of the tumor from the anal margin was ≥12cm according to the results of intraoperative examination or preoperative imaging examination.

• Completion of surgical resection of tumors with negative margins (R0 resection) and at least 3 months of adjuvant chemotherapy based on 5-fluorouracil (5-FU). \*

\*4 cycles of CAPOX (capecitabine and oxaliplatin), 6 cycles of FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or 4 cycles of single agent-5-FU, etc.

• Within 3 months after the completion of adjuvant chemotherapy.
• Patients with Stage IIIB or IIIC disease.\*

\*IIIB: T3-T4aN1/N1cM0, T2-T3N2aM0 and T1-T2N2bM0, IIIC: T4aN2aM0, T3-T4aN2bM0 and T4bN1-N2M0, as defined by the American Joint Committee on Cancer (AJCC) 8th edition).

• Aged 20-80 years, men or women.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• With no radiographic evidence of tumor recurrence.
• Sign the informed consent form.

Exclusion criteria

• Presence of other malignancies in the past 5 years except curatively treated basal cell carcinoma or cervical carcinoma in situ.
• Besides adjuvant chemotherapy, other adjuvant therapy such as radiotherapy, targeted therapy and immunotherapy has been used to treat colon cancer.
• Antitumor Chinese patent medicine and decoction have been used for more than 3 months after surgery or within 1 month before enrollment.
• Patients with severe comorbidities such as cardiovascular, cerebrovascular, renal, hepatic, hematopoietic system and other severe primary diseases.
• Allergic to the ingredients of XLJDOD.
• Any condition that is unstable or can jeopardize the safety of the patients and their compliance to the study, including pregnancy, plan to be pregnant, lactation and psychiatric disorders (schizophrenia, depression, and obsessive-compulsive disorder, etc.).
• Suspected or confirmed history of alcohol and drug abuse.
• Patients with other conditions considered by the investigator should not participate in the study.
• Patients who have recently participated in or are currently participating in other clinical trials of drugs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Jiangsu Province Hospital of Traditional Chinese Medicine — Nanjing

Publications

• Geng X, Wang Z, Feng L, Gu Y, Wang R, Yao Q, Xu Y, Wu J, Jiang Z, Chen K, Hu W, Tang D, Huo J, Li L, Bu Q, Zhao S, Zhang B, Cheng H. Efficacy and safety of Xian-Lian-Jie-Du optimization decoction as an adjuvant treatment for prevention of recurrence in patients with stage IIIB/IIIC colon cancer: study protocol for a multicentre, randomized controlled trial. BMC Complement Med Ther. 2023 Jul 17;23( PMID 37461034

Identifiers

NCT: NCT05709249 · 2022NL-203-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗