Actively Recruiting
A Randomized Controlled Clinical Study on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package
Led by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Updated on 2025-02-17
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Chemotherapy with platinum and taxane drugs often causes chemotherapy-induced peripheral neuropathy (CIPN), affecting 73% to 83% of patients. This condition can limit daily activities, cause injuries, and negatively impact quality of life. Western medicine currently lacks effective clinical treatments, so this study evaluates traditional Chinese medicine hot packs as a potential treatment for CIPN by comparing nerve damage levels between patients receiving this treatment and a control group. The study randomly assigned 90 patients into two groups of 45 each. The control group received standard chemotherapy with paclitaxel and platinum administered at 180 ml/h along with routine health guidance. The intervention group received the same chemotherapy and nursing care plus traditional Chinese medicine hot pack treatment applied to acupuncture points, with home care education provided via a WeChat group. Treatment involved fixing a heated herbal package at 40-50 °C on acupuncture points for 30 minutes daily, avoiding treatment on chemotherapy days and the day after. Participants are assessed for peripheral neuropathy symptoms 14 days after every two chemotherapy cycles using patient-reported scales including NCI-CTCAE, FACT/GOG-Ntx, and KPSS scores. Researchers measure sensory and motor neuropathy along with numbness, tingling, joint pain, hearing difficulties, pace impairment, and fine sensation over six months. The study includes continuous safety monitoring and aims to evaluate the effects of the traditional Chinese medicine hot packs alongside routine care over this period.
CONDITIONS
Brief Title
A Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult and kinetic patients expected to survive with tumor for more than 1 year
- Patients using platinum combined with paclitaxel chemotherapy for the first time
- Voluntarily agree to participate and sign a consent form
You will not qualify if you...
- Allergy to platinum, paclitaxel, or Chinese herbal medicine ingredients
- Patients with diabetes mellitus, Raynaud's syndrome, or central/peripheral nerve disease symptoms
- Unable to judge own symptoms
- Pregnant or lactating women
- Advanced rheumatoid arthritis, severe joint deformity, or incapacitation
- Other immune system diseases
- Incomplete chemotherapy regimen
- Missed hot acupuncture point treatment 3 or more times per week
- Incomplete clinical data collection
- Voluntary withdrawal or unwillingness to continue treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of chemotherapy cycles (not specified)
Participants receive chemotherapy with paclitaxel and platinum following a strict drug-use routine. The intervention group additionally receives traditional Chinese medicine hot package acupoint treatment and home care, including daily application of heated herbal packets on acupuncture points, except on chemotherapy days and the following day.
Assessments for peripheral neuropathy occur on the 14th day after every two rounds of chemotherapy
Duration - Up to 6 months
Participants are monitored for sensory and motor neuropathy, as well as other symptoms such as numbness, joint pain, hearing difficulties, and pace impairment for up to 6 months after treatment.
Periodic assessments during the 6 months post-treatment
Trial Site Locations
Total: 1 location
1
the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine
Yiwu, Zhejiang, China, 322000
Actively Recruiting
Research Team
L
Lin Dong, Bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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