Herbal Treatment to Improve Chemotherapy Delivery

• Status: Recruiting
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Collaborators: Beijing Cancer Hospital; Beijing Chao Yang Hospital; Beijing University of Chinese Medicine; Chongqing University Cancer Hospital; Civil Aviation General Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Henan Provincial People's Hospital; Jiangsu Province Hospital of Traditional Chinese Medicine; Peking University Third Hospital; Shanghai Zhongshan Hospital; Tianjin Union Medical Center; Zhengzhou Hospital of Traditional Chinese Medicine

Criteria

Inclusion Criteria:

• 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:

1. T4 tumor,

2. inadequately sampled nodes (<12 lymph nodes),

3. clinical presentation with bowel obstruction or perforation,

4. poorly differentiated histology ,exclusive of those cancers that are High degree of microsatellite instability(MSI-H),

5. 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.

Exclusion Criteria:

• 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