Clinical trial NCT06492083: A Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package
Official title: A Randomized Controlled Clinical Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy
Keywords: Chemotherapy-Induced Peripheral Neuropathy/CIPN
hot compress with chinese herbal packets
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensory neuropathy
timeFrame: 6 months
measure: Motor neuropathy Motor neuropathy
timeFrame: 6 months
Secondary outcomes:
measure: Numbness, tingling sensation or comfortlessness in the limbs
timeFrame: 6 months
measure: Joint muscle pain
timeFrame: 6 months
measure: Hearing difficulties Hearing difficulties or tinnitus
timeFrame: 6 months
measure: Pace impairment
timeFrame: 6 months
measure: Sense of small objects
timeFrame: 6 months
Other outcomes:
Locations:
city: Yiwu
country: China
facility: the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine
state: Zhejiang
Study officials:
affiliation: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
name: Lin Dong, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: