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NCT Number: NCT06492083

A 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Yiwu, Zhejiang, 322000, China

Location status: Recruiting

Location contact

lin dong

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

traditional Chinese medicine hot bag

Other

traditional Chinese medicine hot bag

Primary outcomes

  1. Sensory neuropathy

    Time frame: 6 months

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

  2. Motor neuropathy Motor neuropathy

    Time frame: 6 months

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

Secondary outcomes

  1. 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.

  2. Joint muscle pain

    Time frame: 6 months

    Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.

  3. 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.

  4. Pace impairment

    Time frame: 6 months

    Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.

  5. Sense of small objects

    Time frame: 6 months

    Functional assessment of cancer therapy /gynaecologic oncology group-neuro-toxicity.Scoring from 0 to 4.

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Dong, Bachelor

CONTACT

[email protected]

86+13634187314

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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