Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Patients(BCS) With Digestive Tract .
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Guangdong
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Guangzhou, Guangdong, China
- Recrutamento
- First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
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Contato:
- lin lizhu, Dr.
- Número de telefone: 13501505588
- E-mail: 13501505588@163.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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:
- clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, etc.
- serious clinical infection of activity (greater than 3 degrees nci-ctcae 4.03)
- uncontrolled hypertension (systolic pressure is greater than 160 mmHg or diastolic pressure is greater than 100 mmHg, despite the best drug treatment);
- 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.
- other diseases that need to be controlled: pulmonary congestion, etc.
- 2. Patients with symptoms, uncontrollable nerves, mental illness or mental disorders;
- 3. Compliance.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: shenqifuzheng
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500ml shenqifuzheng daily（at day 1-14 and day22-36）through intravenous infusion.
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Comparador de Placebo: 0.9%sodium chloride
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500ml sodium chloride（0.9%）daily（at
day 1-14 and day22-36）through intravenous infusion.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Piper Fatigue Scale（PFS）
Prazo: 42 days
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Change From Baseline in Piper Fatigue Scores at 42 days
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42 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: lin lizhu, Dr., First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- livzon-sqfz-BCS
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