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

Sponsors

Lead Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Collaborator: Beijing University of Chinese Medicine
Peking University Third Hospital
Beijing Chao Yang Hospital
Jiangsu Province Hospital of Traditional Chinese Medicine
Shanghai Zhongshan Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Tianjin Union Medical Center
Henan Provincial People's Hospital
Zhengzhou Hospital of Traditional Chinese Medicine
Beijing Cancer Hospital
Chongqing University Cancer Hospital
Civil Aviation General Hospital

Source Xiyuan Hospital of China Academy of Chinese Medical Sciences
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.

Detailed Description

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.

Overall Status Recruiting
Start Date 2018-12-12
Completion Date 2021-05-31
Primary Completion Date 2021-05-31
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Completion Rate of 8-cycle Adjuvant Chemotherapy 6months
Secondary Outcome
Measure Time Frame
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
Time of Dose Reductions of Adjuvant Chemotherapy for the First Time 6months
Time of Dose Reductions of Adjuvant Chemotherapy for the Second Time 6months
Proportion of Salvage Treatment 6months
Incidence of a Chemo-induced Grade 3-4 Nausea/Vomiting 6 months
Incidence of a Chemo-induced Grade 2 Diarrhea 6 months
Changes of Participants' ESAS Score 6 months
Changes of Participants' FACT-C Score 6months
Changes of TCM Symptoms Score 6months
Changes of Spleen Deficiency Scale Score 6months
Changes of Kidney Deficiency Scale Score 6months
Incidence of AEs 6months
Incidence of SAEs 6months
Enrollment 400
Condition
Intervention

Intervention Type: Drug

Intervention Name: Tonifying Spleen and Kidney Sequential Regimen

Description: 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.

Arm Group Label: TCM group

Other Name: TSKSR

Intervention Type: Drug

Intervention Name: Placebo of 'Tonifying Spleen and Kidney Sequential Regimen

Description: 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.

Arm Group Label: Placebo group

Other Name: Placebo of TSKSR

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Yufei Yang, M.D. Principal Investigator Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
Overall Contact

Last Name: Yufei Yang, M.D.

Phone: 8613701366913

Email: [email protected]

Location
Facility: Status: Contact:
Beijing Chao Yang Hospital | Beijing, Beijing, 100020, China Recruiting Minzhe Li, M.D.
Civil Aviation General Hospital | Beijing, Beijing, 100025, China Recruiting Jianping Cheng
Oncology Department of Xiyuan Hospital of China Academy of Chinese Medical Sciences | Beijing, Beijing, 100091, China Recruiting Yun Xu, M.D. 86 10 62835355 [email protected]
Beijing Cancer Hospital | Beijing, Beijing, 100142, China Recruiting Aiwen Wu, M.D. 13911577190
Chongqing University Cancer Hospital | Chongqing, Chongqing, 400030, China Recruiting Wei Wang
Guangdong Provincial Hospital of Traditional Chinese Medicine | Guangdong, Guangzhou, 510120, China Recruiting Jin Wan, M.D.
The Third People's Hospital of Zhengzhou | Zhengzhou, Henan, 450000, China Recruiting Yang Cao
Henan Provincial People's Hospital | Zhengzhou, Henan, 450003, China Recruiting Shundong Cang, M.D. 13592675836
Zhengzhou Hospital of Traditional Chinese Medicine | Zhengzhou, Henan, 450007, China Recruiting Baozhu Zeng 13838520891
Jiangsu Province Hospital of Traditional Chinese Medicine | Nanjing, Jiangsu, 210029, China Recruiting Peng Shu, M.D.
Shanghai Zhongshan Hospital | Shanghai, Shanghai, 200032, China Recruiting Tianshu Liu, M.D.
Tianjin Union Medical Center | Tianjin, Tianjin, 300121, China Recruiting Huaqing Wang, M.D.
Location Countries

China

Verification Date

2020-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: TCM group

Type: Experimental

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

Label: Placebo group

Type: Placebo Comparator

Description: 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.

Acronym HATCHED
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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