An interventional study of Chinese traditional medicine nursing combined with case tracking management and Health Education in Cancer, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Prevention
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.
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 130 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Chinese traditional medicine nursing combined with case tracking management
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.
Other: Health Education
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.
Also known as: Health 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.
Incidence of HFS
Number of HFS patients / total number of patients included in each group
Time frame: At the end of 42 days of chemotherapy for the patient
EORTC-QOL-C30
QoL was measured by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire （EORTC-QOL-C30）
Time frame: At the end of 42 days of chemotherapy for the patient
Plan to share: No — The data that support the findings of this study are available on reasonable request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Started Jan 2021 (actual). Primary completion is estimated for Jun 2024, 41 months after the start.
Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 41 months is above that.
Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.
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