Clinical Value of Prick Therapy Combined With Wheat Grain Moxibustion in the Treatment of Spleen Deficiency and Dampness Obstructed Cancer

Study Overview
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Brief Summary
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This study aims to investigate the clinical efficacy and associated immune and inflammatory mechanisms in patients with malignant tumors of spleen deficiency and dampness resistance type, by applying pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points.

Official Title
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Exploring the Therapeutic Effect of Pricking Therapy Combined With Wheat Grain Moxibustion on Malignant Tumors of Spleen Deficiency and Dampness Resistance Type

Conditions
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Pricking Therapy on the Back Shu Points, Wheat Grain Moxibustion on the Back Shu Points

Intervention / Treatment
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* Other: pricking therapy and wheat grain moxibustion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Western medicine and traditional Chinese medicine for malignant tumors; Clinical diagnosis of spleen deficiency dampness obstruction in traditional Chinese medicine; Good compliance and signed informed consent form. Exclusion Criteria: Patients who cannot lie prone for a long time; Pregnant women; Lactating women
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pricking therapy and wheat grain moxibustion combined with chemotherapy<br>pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points combined with chemotherapy | Other: pricking therapy and wheat grain moxibustion<br>* pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points<br>|
| Active Comparator: chemotherapy<br>Conventional chemotherapy regimen | Other: pricking therapy and wheat grain moxibustion<br>* pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (ORR) | Evaluate the objective response rate (ORR) of subjects based on RECIST V1.1 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival (PFS), | Evaluate subjects' progression free survival (PFS), overall survival (OS), and duration of remission (DOR) based on RECIST V1.1 | 5 years | 
| overall survival (OS) | Evaluate subjects' overall survival (OS) based on RECIST V1.1 | 5 years | 
| duration of remission (DOR) | Evaluate subjects' duration of remission (DOR) based on RECIST V1.1 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spleen deficiency and dampness obstructed, cancer