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

Not Applicable

Recruiting

• Conditions: Pricking Therapy on the Back Shu Points; Wheat Grain Moxibustion on the Back Shu Points
• Interventions: Other: pricking therapy and wheat grain moxibustion

• Registration Number: NCT06074718
• Lead Sponsor: Jiangsu Taizhou People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-10
• Study Start: 2024-01-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pricking therapy and wheat grain moxibustion combined with chemotherapy	pricking therapy and wheat grain moxibustion	pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points combined with chemotherapy
chemotherapy	pricking therapy and wheat grain moxibustion	Conventional chemotherapy regimen

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (ORR)	3 years	Evaluate the objective response rate (ORR) of subjects based on RECIST V1.1

Secondary Outcome Measures

Name	Time	Method
duration of remission (DOR)	5 years	Evaluate subjects' duration of remission (DOR) based on RECIST V1.1
progression free survival (PFS),	5 years	Evaluate subjects' progression free survival (PFS), overall survival (OS), and duration of remission (DOR) based on RECIST V1.1
overall survival (OS)	5 years	Evaluate subjects' overall survival (OS) based on RECIST V1.1

Trial Locations

Locations (1)

Qingtao Ni; 🇨🇳 Taizhou, Jiangsu, China