Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441513
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
The Preventive Effect of Chemotherapy-induced Hand-foot Syndrome
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 50-606 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 abnormalitiessensory insensitivity numbness at the ends of the fingerstoes 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None