A Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package

February 14, 2025 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

A Randomized Controlled Clinical Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package

The combination of platinum and taxane drugs has a chemotherapy-induced peripheral neuropathy (CIPN) rate of 73% to 83%. Its symptoms can not only limit daily activities and cause a variety of accidental injuries, but also easily cause negative emotions and seriously affect the quality of life. Modern Western medicine lacks effective clinical intervention methods, and the treatment of acupuncture points with traditional Chinese medicine is simple to operate, easy to observe adverse reactions, and is suitable for continuous self-treatment outside the hospital after training, saving patients time to travel to and from the hospital, and high patient acceptance. Due to the similarity of the pathogenesis of some traditional Chinese and Western medicine in CIPN and the effectiveness of its application in patients with DPN, this study evaluated the effect of specific formulations of Chinese medicine on CIPN by comparing the degree of nerve damage between the following formulations of Chinese medicine hot packs in patients with platinum combined with paclitaxel chemotherapy and the control group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A random group generator was used to divide the sample of 90 cases, and 45 cases in the control group and 45 cases in the intervention group.

Control group: The chemotherapy was strictly followed by the drug use routine, administered by central vein, paclitaxel and platinum administration rate were set at 180ml/h, and routine health guidance was given before and after chemotherapy.

Intervention group: In addition to the usual nursing measures of the control group, traditional Chinese medicine hot bao acupoint treatment and home care were used.

Patients in both the intervention and control groups were assessed for peripheral neuropathy on the 14th day after the completion of each two rounds of chemotherapy, and the NCI-CTCAE, FACT/GOG-Ntx, and KPSS score scales were assigned according to the patient-reported outcomes.

Study Type

Interventional

Enrollment (Estimated)

90

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
    • Zhejiang
      • Yiwu, Zhejiang, China, 322000
        • Recruiting
        • the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine
        • Contact:
          • Lin Dong

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult and kinetic patients expected survive with tumor for more than 1 year. Those who use platinum in combination with paclitaxel for chemotherapy for the first time; Voluntarily agree to participate and sign a consent form

Exclusion Criteria:

  • Those who are allergic to platinum, paclitaxel or Chinese herbal medicine ingredients; Patients with diabetes mellitus, Raynaud's syndrome, central or peripheral nerve disease symptoms; Those who cannot judge their own symptoms; Pregnant / lactating women; Patients with advanced rheumatoid arthritis, severe joint deformity or incapacitation; Those with other immune system diseases； Patients who have not completed the chemotherapy regimen; Patients who were not treated with hot acupuncture points as prescribed (missed dosing ≥ 3 times per week); Incomplete collection of clinical data; Subjects who voluntarily request to withdraw from this treatment, or are unwilling to continue treatment.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
All chemotherapies were strictly followed by drug-use routine. The paclitaxel and platinum administration rate were set as 180ml/h. Health guidance should provide before and after chemotherapies, including precautions for chemotherapy, dietary guidance, life guidance, etc. For patients with peripheral neuropathy that gradually worsen and affect muscle and joint functions, environmental management and self-management should be guided to prevent from falls, bumps, scalds, frostbite, sharps and other accidents.
Experimental: observation group
In addition to the usual nursing measures of the control group, traditional Chinese medicine was used for acupoint treatment and home care：Patients are consulted by TCM specialist nurses and join the WeChat group to complete the hot package home care health education. Heat herbal packets and keep the temperature at 40-50 °C, fix the hot bag on the corresponding acupuncture points of each limb for 30 minutes. Chemotherapy should not be used on the same day and the next day, and the rest of the time should be treated with hot package every day.
Other: traditional Chinese medicine hot bag
traditional Chinese medicine hot bag

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory neuropathy
Time Frame: 6 months
National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring form 1 to 5 degree.
6 months
Motor neuropathy Motor neuropathy
Time Frame: 6 months
National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring from 1 to 5 degree.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbness, tingling sensation or comfortlessness in the limbs
Time Frame: 6 months
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
6 months
Joint muscle pain
Time Frame: 6 months
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
6 months
Hearing difficulties Hearing difficulties or tinnitus
Time Frame: 6 months
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
6 months
Pace impairment
Time Frame: 6 months
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
6 months
Sense of small objects
Time Frame: 6 months
Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.
6 months

Collaborators and Investigators

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

Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Investigators

  • Principal Investigator: Lin Dong, Bachelor, The Fourth Affiliated Hospital of Zhejiang University School of Medicine

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)

October 30, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KY-2024-076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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