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Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Patients(BCS) With Digestive Tract .

5. marts 2018 opdateret af: Livzon Pharmaceutical Group Inc.

The Efficacy and Safety of Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Patients(Palliative Care) With Digestive Tract Were Prospectively, Randomized Blind, Multicenter Clinical Trials

The efficacy and safety of cancer patients in patients with gastrointestinal cancer (Palliative care) in patients with gastrointestinal tumor (chemotherapy) were prospectively, randomized blind, multicenter clinical trials. They were randomly divided into 2 groups, test group Shenqifuzheng injection of 500 ml, the control group 0.9% sodium chloride injection, 500 ml, intravenous drip, 1 times a day, 14 days post, rest is 7 days, 21 days each for a period of treatment, observation of two procedures. At the same time, according to the NCCN guide and the health ministry issued the diagnosis and treatment guidelines for cancer treatment. The main curative effect of the clinic was to evaluate the pretreatment of cancer due to the fatigue score of the patients before and after treatment -- the Piper fatigue revision scale was used to evaluate the Chinese version. Assess effectiveness and safety based on clinical assessment

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Factors for the purpose of this study by observing theShenqifuzheng injection before and after treatment in patients with carcinoma due to fatigue scale scores, the classification of syndromes, the quality of life score changes and related laboratory index, evaluation factors ginseng and astragalus injection on the digestive tract tumor (chemotherapy) in patients with cancer-related fatigue and quality of life improved efficacy and safety. The experimental group was randomly divided into 2 groups, experimental group Shenqifuzheng injection of 500 ml. The control group was 0.9% sodium chloride injection, 500ml, intravenous drip, 1 time daily, 14 days for continuous use, 7 days of rest, and 1 treatment for each 21 days, and 2 courses were observed. At the same time, according to the NCCN guide and the health ministry issued the diagnosis and treatment guidelines for cancer treatment.

Main efficacy evaluation indexes before and after treatment for cancer-related fatigue rating - adopting the Piper fatigue scale revised Chinese version, compare the experimental group and the control group before and after treatment cancer-related fatigue rating difference have differences. Secondary efficacy evaluation index to compare the ECOG score difference before and after the treatment, the quality of life score difference before and after the treatment, TCM syndrome curative effect, single symptom curative effect of immune function, tumors had curative effect (if any) and chemotherapy completion. Safety assessment includes the observation of vital signs, blood routine, urinary routine, routine stool, liver function, renal function, electrocardiogram examination, and adverse reactions during the treatment.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Rekruttering
        • First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 1. Patients with gastric cancer, esophageal cancer or colorectal cancer diagnosed by pathology or cytology;
  • 2. Diagnostic criteria for cancer-related fatigue;
  • 3. Syndrome differentiation of Chinese medicine is a syndrome of lung temper;
  • 4. Estimated survival over 3 months;
  • 5. ECOG score is less than or equal to 3
  • 6. Age 18 ~ 80 years old；
  • 7. Non-surgical indications or reluctance to operate the surgical treatment;
  • 8. 70 g/L or higher HGB;
  • 9. Stop and chemotherapy for more than 1 month;
  • 10. The patient is willing to accept the treatment of the programme, and can follow the doctor's advice to take the medicine and comply with the patient.

Exclusion Criteria:

  • 1. Any situation that may hinder the subject from completing the clinical trial, including but not limited to serious, uncontrollable organic disease or infection:

    1. clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, etc.
    2. serious clinical infection of activity (greater than 3 degrees nci-ctcae 4.03)
    3. uncontrolled hypertension (systolic pressure is greater than 160 mmHg or diastolic pressure is greater than 100 mmHg, despite the best drug treatment);
    4. severe liver and kidney function abnormality (blood creatinine is greater than 1.5 times ULN; ALT or AST is greater than 5 times ULN; Bilirubin is greater than 1.5 times ULN.
    5. other diseases that need to be controlled: pulmonary congestion, etc.
  • 2. Patients with symptoms, uncontrollable nerves, mental illness or mental disorders;
  • 3. Compliance.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: shenqifuzheng
Medicin: shenqifuzheng injection
500ml shenqifuzheng daily（at day 1-14 and day22-36）through intravenous infusion.
Placebo komparator: 0.9%sodium chloride
Medicin: Sodium Chloride Injection 0.9%
500ml sodium chloride（0.9%）daily（at day 1-14 and day22-36）through intravenous infusion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Piper Fatigue Scale（PFS）
Tidsramme: 42 days
Change From Baseline in Piper Fatigue Scores at 42 days
42 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Livzon Pharmaceutical Group Inc.

Efterforskere

  • Ledende efterforsker: lin lizhu, Dr., First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. januar 2018

Primær færdiggørelse (Forventet)

30. december 2019

Studieafslutning (Forventet)

30. december 2019

Datoer for studieregistrering

Først indsendt

26. december 2017

Først indsendt, der opfyldte QC-kriterier

5. marts 2018

Først opslået (Faktiske)

7. marts 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. marts 2018

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • livzon-sqfz-BCS

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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