Trial Title:
The Preventive Effect of Chemotherapy-induced Hand-foot Syndrome
NCT ID:
NCT06441513
Condition:
Cancer
Conditions: Official terms:
Hand-Foot Syndrome
Conditions: Keywords:
Hand foot syndrome
Case Tracking management
TCM External Treatment Nursing
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
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:
Intervention type:
Other
Intervention name:
Chinese traditional medicine nursing combined with case tracking management
Description:
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.
Arm group label:
Invention group
Other name:
Health Education
Intervention type:
Other
Intervention name:
Health Education
Description:
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.
Arm group label:
Control group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yamei Chen
Phone:
13910003135
Email:
chenyamei3@126.com
Start date:
January 1, 2021
Completion date:
July 1, 2024
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06441513
