Preventing hand-foot syndrome in cancer patients using traditional Chinese medicine
The Preventive Effect of Chinese Traditional Medicine Nursing Combined With Case Tracking Management on Chemotherapy-induced Hand-foot Syndrome: a Randomized Controlled Study
This study is testing whether traditional Chinese medicine baths can help prevent hand-foot syndrome in cancer patients undergoing chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06441513 on ClinicalTrials.gov |
What this trial studies
This study aims to prevent hand-foot syndrome (HFS), a common side effect of chemotherapy, by utilizing traditional Chinese medicine baths combined with case tracking management. It will involve a randomized controlled trial design to monitor patients undergoing chemotherapy at Peking University Third Hospital who do not exhibit HFS symptoms. The intervention focuses on nursing measures that aim to reduce the incidence of HFS and improve patient quality of life during cancer treatment. The study will assess the effectiveness of these nursing interventions in preventing the onset of HFS.
Who should consider this trial
Good fit: Ideal candidates for this study are chemotherapy patients aged 18 to 65 who do not currently exhibit symptoms of hand-foot syndrome.
Not a fit: Patients with pre-existing nerve trauma, diabetic neuropathy, or skin lesions on their hands and feet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of hand-foot syndrome in chemotherapy patients, enhancing their quality of life and treatment adherence.
How similar studies have performed: While traditional Chinese medicine has been explored in various contexts, this specific approach to preventing hand-foot syndrome in chemotherapy patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) no HFS symptoms in chemotherapy patients; (2) Ages 18 to 65 years; (3) Estimated survival ≥ 3 months; (4) There was no dysfunction of major organs, heart, liver and kidney functions were basically normal, and the laboratory indicators met the following requirements: neutrophils \> 1.5 × 109/l, platelets \> 100 × 109/l, hemoglobin \> 90g/l; Bilirubin was normal or \< 1.5 × ULN; AST and alt \< 2.5 × ULN; Serum creatinine \< 1.5 × ULN; Endogenous creatinine clearance (CCR) ≥ 60ml/min. (5) Those who can understand the situation of this study, can cooperate in the assessment of HFS grading, and have signed the informed consent. Exclusion Criteria: * (1) history of nerve trauma before chemotherapy, diabetic neuropathy, spinal cord compression syndrome without surgical treatment, spinal canal stenosis or spinal cord nerve root compression, and central nervous system tumors; (2) Patients with skin lesions of hands and feet; (3) Those who have plans to use other drugs that may affect HFS (including urea cream, vitamin B6, celecoxib, compound Sophora flavescens injection, calf blood deproteinized extract intravenous injection); (4) Patients with severe, uncontrolled organic lesions or infections, such as decompensated heart, lung, renal failure, etc., that lead to intolerance to chemotherapy; (5) Those who participate in other clinical trials at present or within 4 weeks; (6) Obvious neurological and psychiatric history, including dementia or epilepsy that may affect understanding and informed consent; (7) Intolerant or allergic to the traditional Chinese medicine prescriptions in this study.
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yamei Chen
- Email: chenyamei3@126.com
- Phone: 13910003135
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.