Treatment for chemotherapy-induced peripheral neuropathy using traditional Chinese medicine hot packages
A Randomized Controlled Clinical Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package
NA · The Fourth Affiliated Hospital of Zhejiang University School of Medicine · NCT06492083
This study is testing if traditional Chinese medicine hot packages can help people with chemotherapy-induced nerve pain feel better while they are undergoing treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Yiwu, Zhejiang) |
| Trial ID | NCT06492083 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of traditional Chinese medicine hot packages in treating chemotherapy-induced peripheral neuropathy (CIPN) in patients undergoing chemotherapy with platinum and taxane drugs. A total of 90 participants will be randomly assigned to either a control group, receiving standard chemotherapy care, or an intervention group, which will also receive hot compress treatments at acupuncture points. The study aims to assess the degree of nerve damage and patient-reported outcomes after chemotherapy cycles. The approach combines modern chemotherapy with traditional Chinese medicine to potentially improve patient quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing their first chemotherapy regimen with platinum and paclitaxel, expected to survive with their tumor for more than one year.
Not a fit: Patients with allergies to the chemotherapy drugs or Chinese herbal ingredients, as well as those with certain pre-existing conditions like diabetes or severe joint deformities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms of CIPN, improving the quality of life for patients undergoing chemotherapy.
How similar studies have performed: While traditional Chinese medicine has been used in various contexts, this specific approach to CIPN treatment is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Yiwu, Zhejiang
- the Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine — Yiwu, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Lin Dong, Bachelor — The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Study coordinator: Lin Dong, Bachelor
- Email: dong13634187314@163.com
- Phone: 86+13634187314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chemotherapy, Chemotherapy-Induced Peripheral Neuropathy/CIPN, hot compress with chinese herbal packets