Clinical trial · Interventional
The Preventive Effect of Chemotherapy-induced Hand-foot Syndrome
The Preventive Effect of Chinese Traditional Medicine Nursing Combined With Case Tracking Management on Chemotherapy-induced Hand-foot Syndrome: a Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
this study will use traditional Chinese medicine bath with no obvious side effects combined with case tracking management mode to form nursing measures to prevent hand foot syndrome. A randomized controlled trial design will be used to collect cases of hand foot syndrome (HFS) that did not appear after chemotherapy in the ward of the Department of chemotherapy, Peking University Third Hospital, and carry out nursing intervention.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chinese traditional medicine nursing combined with case tracking management | Other | — | UNRESOLVED |
| Health Education | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Invention group
- description
- On the basis of the intervention measures in the control group, we added the following measures. First, we set up a team for the prevention of hand foot syndrome, including 1 head nurse of the tumor chemotherapy department, 2 doctors, 16 nurses (16 nurses were divided into 4 groups, each group designated a team leader) and the researchers of this experiment. Doctors are responsible for the diagnosis of HFS and the determination of traditional Chinese medicine prescriptions, head nurses and team leaders are responsible for quality control, and nurses are responsible for the assessment, intervention and evaluation of patients.
- interventionNames
- Other: Chinese traditional medicine nursing combined with case tracking management
- type
- OTHER
- label
- Control group
- description
- We distributed traditional Chinese medicine to the control group and carried out health education, which mainly included elaborating the symptoms, mechanism and corresponding treatment measures of HFS for patients, reducing the fear of patients, helping them relax and adjust their mentality, and cooperating with observation. At the same time, we should also try to reduce the chance of skin damage on hands / feet, such as wearing long clothes and pants when going out to avoid direct sunlight; Wear loose shoes, socks and gloves to avoid frequent friction and excessive pressure of hands and feet; Avoid heavy physical labor and intense exercise; Avoid contact with supercooled, overheated, sharp and irritating objects.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- RESULTSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- RESULTMiller KK, Gorcey L, McLellan BN. Chemotherapy-induced hand-foot syndrome and nail changes: a review of clinical presentation, etiology, pathogenesis, and management. J Am Acad Dermatol. 2014 Oct;71(4):787-94. doi: 10.1016/j.jaad.2014.03.019. Epub 2014 May 1. PMID 24795111
- RESULTKanbayashi Y, Taguchi T, Ishikawa T, Otsuji E, Takayama K. Risk Factors of Capecitabine-Induced Hand-Foot Syndrome: A Single-Institution, Retrospective Study. Oncology. 2023;101(7):407-414. doi: 10.1159/000529851. Epub 2023 Apr 19. PMID 37075722
- RESULTKao YS, Lo CH, Tu YK, Hung CH. Pharmacological prevention strategy for capecitabine-induced hand-foot syndrome: A network meta-analysis of randomized control trials. Dermatol Ther. 2022 Oct;35(10):e15774. doi: 10.1111/dth.15774. Epub 2022 Aug 30. PMID 36054263