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Explore the clinical effect and mechanism of thunder fire moxibustion on cancer-related fatigue caused by immune checkpoint inhibitors based on invigorating qi and warming yang theory from hypothalamic pituitary adrenal axis regulatio

Phase 1
Recruiting
Conditions
cancer-related fatigue
Registration Number
ITMCTR2200006558
Lead Sponsor
Shenzhen Hospital (Longgang), Beijing University of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

? Meet the above diagnostic criteria of Traditional Chinese and western medicine;
? KPS=50 points;
? Aged between 18 and 80 years old;
? Have a clear sense of autonomy, fully know the research content, and voluntarily agree to participate in the research;
?Immune function bone marrow reserve and thyroid function of heart, liver, kidney, adrenal gland were basically normal, and there was no history of endocrine diseases.
?Prior systemic treatment with checkpoint inhibitors (ICIs) for more than 4 cycles;
?The expected survival time is 3 months or more;
?With good compliance, can be placed independent posture, good follow-up

Exclusion Criteria

?Complicated with serious primary diseases such as cardio-cerebrovascular system or hematopoietic system, autoimmune system and psycho-nervous system;
?Associated with local skin ulceration infection, high fever and serious systemic infectious diseases;
?Women who are pregnant or breast-feeding or have a recent pregnancy plan, patients with disintegration;
?Patients receiving specialized treatment such as chemoradiotherapy and targeted therapy during the same period, or the washout period is less than 30 days;
?Severe allergic constitution, or definite allergy to excipients/excipients related to Chinese medicine transdermal patch technology, or drug components in thunder and fire moxibustion, or dizzy moxibustion;
?Patients with recent active bleeding or severe coagulation abnormalities (glaucoma, fundus bleeding, traumatic eye bleeding);
?Patients who are using immunosuppressive drugs or long-term use of immunosuppressive drugs after organ transplantation;
?During the use of cephalosporin antibiotics.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Piper Fatigue Scale;
Secondary Outcome Measures
NameTimeMethod
Quality of life score for cancer patients;EORTC-QLQ-C30-version3;??????;
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