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Cola

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

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.

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.

Tonifying Spleen and Kidney Sequential Regimen

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.

Placebo of 'Tonifying Spleen and Kidney Sequential Regimen

Yufei Yang, M.D.

Yun Xu, M.D.

Minzhe Li, M.D.

Jianping Cheng

Aiwen Wu, M.D.

Wei Wang

Jin Wan, M.D.

Yang Cao

Shundong Cang, M.D.

Baozhu Zeng

Peng Shu, M.D.

Tianshu Liu, M.D.

Huaqing Wang, M.D.

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.

CapeOX chemotherapy is a combination therapy of Oxaliplatin 130mg/m\^2 IV on 1st day and Capecitabine 1000mg/m\^2 PO twice daily from 1th day to 14th day,21 days for each course of treatment.Adverse effects of chemotherapy,such as myelosuppression and gastrointestinal reactions,may lead to dose reductions,treatment delays or even discontinuation among cancer patients. According to IDEA study,the completion rate of 8-cycle CapeOX chemotherapy in colorectal cancer patients is 64%,which means that nearly 4 in 10 patients could not complete adjuvant chemotherapy as planned,which may negatively impact patients' survival outcomes.Some prior studies have shown that TCM can improve patients' symptom control and QoL during adjuvant chemotherapy,which may further improve the completion of adjuvant chemotherapy. However,there is a lack of definitive evidence to evaluate the effects of TCM in stage II(high-risk)\& III colon cancer patients who receive adjuvant chemotherapy after radical surgery.The study will be conducted between 2018 and 2021.Four hundred participants will be enrolled and randomly assigned to either the experimental group or the control group.

Herbal Treatment to Improve Chemotherapy Delivery

Effect of TCM-TSKSR on Completion Rates of Chemotherapy in Patients With Stage II & III Colon Cancer: A Randomized Placebo-Controlled Clinical Trial

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

Completion Rate of Adjuvant Chemotherapy of Each Participant=number of the last courses of chemotherapy/8\*100%

Completion Rate of 4-cycle Adjuvant Chemotherapy=number of participants completing 4-cycle adjuvant chemotherapy/number of participants randomized to each group\*100%

TTF is the period from randomization to the earliest day of an event such as withdrawal from protocol treatment for any reasons, patients refusal and loss to follow-up.

Relative dose intensity (RDI) (%) = (actual dose/ initial dose of adjuvant chemotherapy) × 100%

Proportion of Modifications of Time=number of participants delaying chemotherapy /number of participants randomized to each group\*100%.Delay is defined as ≥7days because of adverse event,such as weakness, myelosuppression, gastrointestinal reactions and other toxicity,except for administrative issues related to hospitalization.

It is the period from randomization to when a chemo-induced grade 3-4 granulocytopenia and/or a chemo-induced grade 2 thrombocytopenia is observed in participants for the first time,in which case,the dose of both Oxaliplatin and Capecitabine will be reduced by 25% of planned dosage.

It is the period from randomization to when a chemo-induced grade 3-4 granulocytopenia and/or a chemo-induced grade 2 thrombocytopenia is observed in participants for the second time,in which case,the dose of both Oxaliplatin and Capecitabine will be reduced by 50% of planned dosage.

Proportion of Salvage Treatment=Number of participants receiving salvage treatment/Number of participants randomized to each group\*100%.

Edmonton Symptom Assessment Scale(ESAS) score will be used to evaluate the change of participants' QoL during adjuvant chemotherapy.ESAS has 9 items designed to assess the severity of commonly reported symptoms experienced by cancer patients,including pain, fatigue, drowsiness, nausea, dyspnea, depression, anxiety, well-being, and loss of appetite.Each items ranges from 0 to 10.

Functional Assessment of Cancer Therapy-Colorectal (FACT-C) score will be used to evaluate the change of participants' QoL during adjuvant chemotherapy.The FACT-C consists of 36 items,in four domains of well-being (physical,emotional,social,and functional),on a scale of 0 to 4.

Based on a prior expert consensus,11 TCM symptoms were considered to be the most common symptoms during CapeOX chemotherapy,including vomiting, numbness, diarrhea, constipation, sensation of chill, nocturia, forgetfulness, spontaneous sweating, night sweats, dry mouth and canker sores, each of which ranges from 0 to 10.

Based on prior researches,the investigator designed Spleen Deficiency Scale,which includes 8 items involving appetite,abdominal distension and so on.Each question ranges from 1 to 5.

Based on prior researches,the investigator designed Kidney Deficiency Scale, which includes 8 items involving soreness of waist, tinnitus, and so on. Each question ranged from 1 to 5.

Adverse effects(AEs) includes abnormal results of blood/urine/stool routine examination, liver/renal function test and electrocardiograms.

Serious Adverse effects(SAEs) includes abnormal results of blood/urine/stool routine examination, liver/renal function test and electrocardiograms.

Spots Global Cancer Trial Database for adverse effect of chemotherapy