Clinical efficacy and mechanism observation of acupuncture in improving skeletal muscle consumption in advanced lung cancer cachexia
- Conditions
- Cancer Cachexia
- Registration Number
- ITMCTR1900002392
- Lead Sponsor
- Chongqing Jiulongpo District Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ife qulity score;Muscle mass;Weight;Muscle mass;
- Secondary Outcome Measures
Name Time Method Arm muscle circumference;Tumor seize;CRP;OVerall survice;ALB;Peripheral blood lymphocyte T cells;