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

NCT06492083 | Recruiting

• 1 other identifier: KY-2024-076
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy

Keywords

Chemotherapy-Induced Peripheral Neuropathy/CIPN; hot compress with chinese herbal packets

Outcome Measures

Primary Outcomes (2)

• Sensory neuropathy

  National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring form 1 to 5 degree.

  6 months

• Motor neuropathy Motor neuropathy

  National Cancer Institute-Common Terminology Criteria for Adverse Events. Scoring from 1 to 5 degree.

  6 months

Secondary Outcomes (5)

• Numbness, tingling sensation or comfortlessness in the limbs

  6 months

• Joint muscle pain

  6 months

• Hearing difficulties Hearing difficulties or tinnitus

  6 months

• Pace impairment

  6 months

• Sense of small objects

  6 months

Study Arms (2)

control group

NO INTERVENTION

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.

observation group

EXPERIMENTAL

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

Interventions

traditional Chinese medicine hot bag OTHER

traditional Chinese medicine hot bag

observation group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

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

Yiwu, Zhejiang, 322000, China

RECRUITING

Study Officials

• Lin Dong, Bachelor

  The Fourth Affiliated Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Dong, Bachelor

CONTACT

86+13634187314; dong13634187314@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 9, 2024
• Study Start: October 30, 2024
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)