Effect of Jianpi Huatan Decoction on Advanced Colorectal Cancer
8. januar 2022 oppdatert av: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Efficacy Evaluation of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer and Analysis of Dominant Population Characteristics and Methylation Characteristics
This study will take progression-free survival and overall survival as the main evaluation indexes, to evaluate the Efficacy of Jianpi Huatan Decoction in the Treatment of Advanced Colorectal Cancer.
Decision Trees and Discriminant Analysis will be used to analyze the characteristics of dominant population combined with clinical data of patients.
DNA methylation of the subjects will be detected to study the methylation characteristics of the preponderant population of Jianpi Huatan Decoction.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
200
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yu Wu, Master
- Telefonnummer: 010-62835438
- E-post: zoujianhua2021@163.com
Studer Kontakt Backup
- Navn: Jianhua Zou, Doctor
- Telefonnummer: 18810209092
- E-post: 490943558@qq.com
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100053
- Rekruttering
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
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Ta kontakt med:
- Jianhua Zou, Doctor
- Telefonnummer: 18810209092
- E-post: 490943558@qq.com
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Ta kontakt med:
- Cui Ning, master
- Telefonnummer: 15652590697
- E-post: 809918686@qq.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients with colorectal cancer with clear pathological diagnosis and Western medicine diagnostic criteria.
- TNM classification of stage IV disease according to National Comprehensive Cancer Network (NCCN) Guidelines.
- Expected survival time is over 3 months.
- The age of 18 years old or more.
- According to the efficacy evaluation criteria for solid tumors (RECIST 1.1), there are measurable lesions.
- Chemotherapy and/or targeted therapy are planned.
- Signed informed consent.
Exclusion Criteria:
- History of previous or combined malignancies except non-melanoma skin cancer, cervical cancer in situ, or bladder cancer (Tis and T1) received adequate treatment in the five years prior to screening.
- Combined with severe heart, liver, lung and kidney disease.
- Patients have intestinal obstruction can't take decoction and need intravenous high-energy nutrition. Patients have malabsorption syndrome or other disease affecting gastrointestinal absorption or have active peptic ulcer disease.
- Any unstable condition or condition that may endanger patient safety and compliance with research, such as pregnancy, depression, manic-depressive disorder, obsessive-compulsive disorder, or schizophrenia.
- The expected survival time is less than 3 months.
- The researchers determine that they were not suitable for the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Experimental Group
The experimental group will take Jianpi Huatan dispensing granule while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
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once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
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Placebo komparator: Control Group
The experimental group will take Placebo granule (containing 1/10 of the formula dose of Jianpi Huatan Granule) while receiving chemotherapy and/or targeted therapy, once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
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once a day in the morning and evening, 30 days as a course of treatment, a total of 3 courses.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Progression-free survival
Tidsramme: From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 100 months
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From enrollment until disease progression or death
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From date of randomization until the date of disease progression or date of death from any cause, whichever came first, assessed up to 100 months
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Overall survival
Tidsramme: From date of randomization until the date of death from any cause, assessed up to 100 months
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From enrollment until death or end of the follow-up
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From date of randomization until the date of death from any cause, assessed up to 100 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Survival rate
Tidsramme: 3 years
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The 1-year, 2-year and 3-year survival rates of patients in the treatment group and the control group were analyzed
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3 years
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Disease control rate
Tidsramme: 3 months
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Efficacy was assessed according to RECIST 1.1 at the end of 3 months of treatment.
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3 months
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Cancer fatigue score
Tidsramme: 3 months
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Piper Fatigue Scale will be used.The fatigue of patients will be evaluated from 22 items of behavioral dimension, emotional dimension, sensory dimension and cognitive dimension.
The higher the score of each dimension, the more serious the fatigue degree.
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3 months
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Traditional Chinese Medicine(TCM )symptom grading table
Tidsramme: 3 months
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Effective: after treatment, TCM symptom score decreased by more than 50% compared with that before treatment. Effective: decrease < 50% and equal to 30%; Invalid: decrease < 30%. Note: the formula is: (before treatment - integral after treatment) / before treatment by 100%. |
3 months
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The European Organization for Cancer Research and Treatment Core Quality of Life Questionnaire (EORTC QLQ-C30) score scale
Tidsramme: 3 months
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The raw scores for the scales and single items were linearly transformed to values between 0 and 100 as described in the EORTC QLQ scoring manual.
The mean and standard deviation of each scale/single item were calculated.
A higher score for a functioning scale represented a healthier level of functioning, a higher score for the global health status scale represented a higher QOL, and a higher score for a symptom scale/item represented a worse level of symptomatology.
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3 months
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the United States Eastern Oncology Collaboration Group (ECOG) score scale
Tidsramme: 3 months
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ECOG scoring standard is an indicator of patients' general health status and tolerance to treatment based on their physical strength.
ECOG physical condition rating standard score 0-5 points.
A minimum score of 0 indicates normal activity, a higher score indicates less physical activity, and a score of 5 indicates death.
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3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studiestol: Yu Wu, Master, Xiyuan Hospital of China Academy of Chinese Medical Sciences
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. november 2021
Primær fullføring (Forventet)
1. juli 2024
Studiet fullført (Forventet)
1. juli 2024
Datoer for studieregistrering
Først innsendt
20. desember 2021
Først innsendt som oppfylte QC-kriteriene
8. januar 2022
Først lagt ut (Faktiske)
11. januar 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. januar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. januar 2022
Sist bekreftet
1. november 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CI2021A01803
Plan for individuelle deltakerdata (IPD)
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