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

NCT06074718 | Recruiting

• 1 other identifier: JiangsuTaizhouPH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pricking Therapy on the Back Shu Points; Wheat Grain Moxibustion on the Back Shu Points

Keywords

spleen deficiency and dampness obstructed; cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (ORR)

  Evaluate the objective response rate (ORR) of subjects based on RECIST V1.1

  3 years

Secondary Outcomes (3)

• progression free survival (PFS),

  5 years

• overall survival (OS)

  5 years

• duration of remission (DOR)

  5 years

Study Arms (2)

pricking therapy and wheat grain moxibustion combined with chemotherapy

EXPERIMENTAL

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

chemotherapy

ACTIVE COMPARATOR

Conventional chemotherapy regimen

Other: pricking therapy and wheat grain moxibustion

Interventions

pricking therapy and wheat grain moxibustion OTHER

pricking therapy and wheat grain moxibustion on the back shu points or positive reaction points

chemotherapy; pricking therapy and wheat grain moxibustion combined with chemotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who cannot lie prone for a long time;
• Pregnant women;
• Lactating women

Sponsors & Collaborators

• Jiangsu Taizhou People's Hospital: lead

Study Sites (1)

Qingtao Ni

Taizhou, Jiangsu, 225300, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Qingtao Ni

CONTACT

18852656280; nqt1990@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Project Management Department, Centre for Clinical Research

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: October 10, 2023
• Study Start: January 2, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

CN (1)