Clinical trial NCT06441513: The Preventive Effect of Chemotherapy-induced Hand-foot Syndrome
Official title: The Preventive Effect of Chinese Traditional Medicine Nursing Combined With Case Tracking Management on Chemotherapy-induced Hand-foot Syndrome: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Hand foot syndrome
Case Tracking management
TCM External Treatment Nursing
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of HFS
timeFrame: At the end of 42 days of chemotherapy for the patient
Secondary outcomes:
measure: EORTC-QOL-C30
timeFrame: At the end of 42 days of chemotherapy for the patient
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital Library
name: Yamei Chen
role: STUDY_CHAIR
References:
citation: Sung 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.
citation: Miller 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.
citation: Kanbayashi 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.
citation: Kao 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.