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Herbal Treatment to Improve Chemotherapy Delivery (HATCHED)

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ClinicalTrials.gov Identifier: NCT03716518
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: Tonifying Spleen and Kidney Sequential Regimen Drug: Placebo of 'Tonifying Spleen and Kidney Sequential Regimen Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of TCM-TSKSR on Completion Rates of Chemotherapy in Patients With Stage II & III Colon Cancer: A Randomized Placebo-Controlled Clinical Trial
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: TCM group
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
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.
Other Name: TSKSR

Placebo Comparator: Placebo group
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
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.
Other Name: Placebo of TSKSR




Primary Outcome Measures :
  1. Completion Rate of 8-cycle Adjuvant Chemotherapy [ Time Frame: 6months ]
    Completion Rate of 8-cycle Adjuvant Chemotherapy=number of participants completing 8-cycle adjuvant chemotherapy/number of participants randomized to each group*100%


Secondary Outcome Measures :
  1. Completion Rate of Adjuvant Chemotherapy of Each Participant [ Time Frame: 6months ]
    Completion Rate of Adjuvant Chemotherapy of Each Participant=number of the last courses of chemotherapy/8*100%

  2. Completion Rate of 4-cycle Adjuvant Chemotherapy [ Time Frame: 3months ]
    Completion Rate of 4-cycle Adjuvant Chemotherapy=number of participants completing 4-cycle adjuvant chemotherapy/number of participants randomized to each group*100%

  3. Time to Treatment Failure,TTF [ Time Frame: 6months ]
    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.

  4. Relative Dose Intensity (RDI) of Adjuvant Chemotherapy [ Time Frame: 6months ]
    Relative dose intensity (RDI) (%) = (actual dose/ initial dose of adjuvant chemotherapy) × 100%

  5. Proportion of Modifications of Time [ Time Frame: 6months ]
    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.

  6. Time of Dose Reductions of Adjuvant Chemotherapy for the First Time [ Time Frame: 6months ]
    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.

  7. Time of Dose Reductions of Adjuvant Chemotherapy for the Second Time [ Time Frame: 6months ]
    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.

  8. Proportion of Salvage Treatment [ Time Frame: 6months ]
    Proportion of Salvage Treatment=Number of participants receiving salvage treatment/Number of participants randomized to each group*100%.

  9. Incidence of a Chemo-induced Grade 3-4 Nausea/Vomiting [ Time Frame: 6 months ]
  10. Incidence of a Chemo-induced Grade 2 Diarrhea [ Time Frame: 6 months ]
  11. Changes of Participants' ESAS Score [ Time Frame: 6 months ]
    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.

  12. Changes of Participants' FACT-C Score [ Time Frame: 6months ]
    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.

  13. Changes of TCM Symptoms Score [ Time Frame: 6months ]
    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.

  14. Changes of Spleen Deficiency Scale Score [ Time Frame: 6months ]
    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.

  15. Changes of Kidney Deficiency Scale Score [ Time Frame: 6months ]
    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.

  16. Incidence of AEs [ Time Frame: 6months ]
    Adverse effects(AEs) includes abnormal results of blood/urine/stool routine examination, liver/renal function test and electrocardiograms.

  17. Incidence of SAEs [ Time Frame: 6months ]
    Serious Adverse effects(SAEs) includes abnormal results of blood/urine/stool routine examination, liver/renal function test and electrocardiograms.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716518


Contacts
Contact: Yufei Yang, M.D. 8613701366913 yyfwdbwyy@126.com
Contact: Yun Xu, M.D. 8615210775378 xyxiao78@163.com

Locations
China, Beijing
Beijing Chao Yang Hospital Not yet recruiting
Beijing, Beijing, China, 100020
Contact: Minzhe Li, M.D.         
Oncology Department of Xiyuan Hospital of China Academy of Chinese Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100091
Contact: Yun Xu, M.D.    86 10 62835355    xyxiao78@163.com   
Contact: Yufei Yang, M.D.    86 10 62835355    yyfwdbwyy@126.com   
Peking University Third Hospital Not yet recruiting
Beijing, Beijing, China, 100191
Contact: Tao Sun, M.D.         
China, Guangzhou
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangdong, Guangzhou, China, 510120
China, Jiangsu
Jiangsu Province Hospital of Traditional Chinese Medicine Not yet recruiting
Nanjing, Jiangsu, China, 210029
Contact: Peng Shu, M.D.         
China, Shanghai
Shanghai Zhongshan Hospital Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Tianshu Liu, M.D.         
China, Tianjin
Tianjin Union Medical Center Not yet recruiting
Tianjin, Tianjin, China, 300121
Contact: Huaqing Wang, M.D.         
Sponsors and Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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
Investigators
Principal Investigator: Yufei Yang, M.D. Xi-Yuan Hospital, China Academy of Chinese Medical Sciences

Responsible Party: Xiyuan Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03716518     History of Changes
Other Study ID Numbers: 2017YFC1700604
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiyuan Hospital of China Academy of Chinese Medical Sciences:
Colon Cancer
Traditional Chinese Medicine
Adverse Effect of Chemotherapy
Chemotherapy

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases