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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06441513
Enrollment
130
Registered
2024-06-04
Start date
2021-01-01
Completion date
2024-07-01
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Hand foot syndrome, Case Tracking management, TCM External Treatment Nursing

Brief summary

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.

Detailed description

Chemotherapy drugs have achieved certain satisfactory clinical efficacy in the treatment of cancer, but they can also cause common side effects including digestive tract reactions, skin rashes, hand-foot syndrome, and bone marrow suppression. Among them, hand-foot syndrome (HFS) is a common chemotherapy complication with an incidence rate of up to 50%-60%6. About 17%-24% of patients may develop grade 3 HFS. The main clinical manifestation of HFS is characterized by red plaques and sensory abnormalities on the palms and soles of the hands and feet. The initial symptoms are hyperemia and erythema on the palms and soles, tingling sensation, sensory abnormalities/sensory insensitivity, numbness at the ends of the fingers/toes, followed by tension, pain, dryness, skin desquamation and peeling (small or large flakes of skin lifted) on the hands and feet. In severe cases, blisters, exudation, and even ulcers may occur, accompanied by severe pain. Patients may be unable to walk or hold objects due to pain, and even lose their ability to take care of themselves. Currently, HFS is mainly treated by interrupting chemotherapy, symptomatic analgesia, anti-inflammation, and preventing infection. The occurrence of HFS brings great inconvenience to patients' daily lives, not only affecting their ability to live independently (including general labor and work), but also adding additional economic expenses. More importantly, due to the impact of drug reduction or withdrawal, cancer treatment cannot be carried out smoothly, which has a negative impact on patients' quality of life. Therefore, paying attention to the prevention of hand-foot syndrome is of great clinical significance. At present, domestic and foreign scholars have adopted oral administration of vitamin, mecobalamin and other neuroprotective drugs to prevent HFS, but the incidence of HFS remains high. The analysis of the reasons found that due to the lack of effective management, patients have poor compliance, and patients are worried about the side effects of drugs, which further reduces their compliance. Many domestic studies have found that external treatment of traditional Chinese medicine (including bathing and application) is safe, effective and easy to implement. Moreover, more and more studies have found that traditional Chinese medicine can effectively treat hand-foot syndrome Case tracking management mode is a branch of tracking methodology, which refers to tracking the diagnosis, treatment and nursing process experienced by patients in the whole medical system, evaluating the nursing service of the hospital from the perspective of patients, so that the evaluator can see the whole nursing process from the perspective of patients. In recent years, studies have found that the case tracking management model can quickly find and improve the quality of clinical nursing problems, and has a significant role in promoting high-quality nursing and nursing safety. Therefore, 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.

Interventions

OTHERChinese traditional medicine nursing combined with case tracking management

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.

OTHERHealth Education

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.

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Random numbers were sequentially sealed in a continuously numbered and opaque envelope. The envelopes were opened sequentially to allocate participants to the case tracking management or control group by the other researcher. Because of the nature of continuing care intervention, it was not possible to blind the participants about the intervention.

Intervention model description

The process of randomization and concealment allocation was conducted by a research team who were not involved in the study. Spss26.0 software was used to program and generate a random number table, which was randomly divided into two groups.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of HFSAt the end of 42 days of chemotherapy for the patientNumber of HFS patients / total number of patients included in each group

Secondary

MeasureTime frameDescription
EORTC-QOL-C30At the end of 42 days of chemotherapy for the patientQoL was measured by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QOL-C30)

Countries

China

Contacts

Primary ContactYamei Chen
chenyamei3@126.com13910003135
Backup ContactJing Wang
nmwj0723@163.com13699176380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026