Clinical efficacy and mechanism observation of acupuncture in improving skeletal muscle consumption in advanced lung cancer cachexia

Chongqing Jiulongpo District Hospital of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1 subjects are able to understand and comply with the parameters listed in the protocol and must sign informed consent approved by the independent ethics committee (IEC)/institutional verification committee (IRB) before initiating any screening or study specific procedures;
•2 subjects must be adults aged = 18 years;
•3 patients diagnosed with non-small cell lung cancer by imaging and histopathology and/or cytology;
•4 > 1 grade a hospitals were diagnosed as stage iiiib -IV non-small cell lung cancer;
•5 according to the 2011 Lancet Oncology consensus on the diagnosis and staging of cancer cachcachia, patients with body weight loss of >5% or BMI < 20kg/m2 experienced a body weight loss of > 2% within 6 months, or those with limb muscle index consistent with oligomyopathy (male < 7.26kg/m2 and female < 5.45kg/m2) experienced a body weight loss of > 2%, which was considered as the onset of cachcachia.
•6 according to RECIST version 1.1 tumor efficacy evaluation criteria, the subject's CT scan at least one measurable lesion was suggested in one hospital.
•7 women and men of reproductive age must agree to use appropriate contraceptives before they are enrolled in the study, during the study and during follow-up after completion of the study.Women of reproductive age must have a negative urine pregnancy test within 7 days prior to the start of the study and/or postmenopausal women must be in menopause for at least 12 months before they can be considered infertile.

•1 secondary cachexia of subjects with malignant intestinal obstruction;
•2 according to the NCI common adverse event evaluation criteria (NCI CTCAE), the subjects had encephalopathy above grade 2;
•3 subjects' left ventricular ejection fraction <50%;
•4 diseases other than clinically significant uncontrolled tumors that affect patient survival;
•5 severe heart, liver and kidney diseases, diabetes mellitus, rheumatoid arthritis, and chronic obstructive pulmonary disease;
•6 complicated with diseases of the blood system;
•7 female subjects during pregnancy or lactation.

发起方

Chongqing Jiulongpo District Hospital of Traditional Chinese Medicine