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

May 7, 2024 updated by: niqingtao, Jiangsu Taizhou People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Taizhou, Jiangsu, China, 225300
        • Recruiting
        • Qingtao Ni
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (ORR)
Time Frame: 3 years
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),
Time Frame: 5 years
Evaluate subjects' progression free survival (PFS), overall survival (OS), and duration of remission (DOR) based on RECIST V1.1
5 years
overall survival (OS)
Time Frame: 5 years
Evaluate subjects' overall survival (OS) based on RECIST V1.1
5 years
duration of remission (DOR)
Time Frame: 5 years
Evaluate subjects' duration of remission (DOR) based on RECIST V1.1
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Taizhou People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JiangsuTaizhouPH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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