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

Last updated: February 14, 2025
Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chemotherapy

Treatment

traditional Chinese medicine hot bag

Clinical Study ID

NCT06492083
KY-2024-076
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: traditional Chinese medicine hot bag
Phase:
Study Start date:
October 30, 2024
Estimated Completion Date:
October 30, 2025

Study 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.

Connect with a study center

  • the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine

    Yiwu, Zhejiang 322000
    China

    Active - Recruiting

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