Ignite Creation Date:
2024-07-17 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492083
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-18
Brief Title:
A Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package
Sponsor:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Organization:
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study Overview
Official Title:
A Randomized Controlled Clinical Stuty on the Treatment and Nursing Care of CIPN Patients With Traditional Chinese Medicine Hot Package
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The combination of platinum and taxane drugs has a chemotherapy-induced peripheral neuropathy CIPN rate of 73 to 83 Its symptoms can not only limit daily activities and cause a variety of accidental injuries but also easily cause negative emotions and seriously affect the quality of life Modern Western medicine lacks effective clinical intervention methods and the treatment of acupuncture points with traditional Chinese medicine is simple to operate easy to observe adverse reactions and is suitable for continuous self-treatment outside the hospital after training saving patients time to travel to and from the hospital and high patient acceptance Due to the similarity of the pathogenesis of some traditional Chinese and Western medicine in CIPN and the effectiveness of its application in patients with DPN this study evaluated the effect of specific formulations of Chinese medicine on CIPN by comparing the degree of nerve damage between the following formulations of Chinese medicine hot packs in patients with platinum combined with paclitaxel chemotherapy and the control group
Detailed Description:
A random group generator was used to divide the sample of 90 cases and 45 cases in the control group and 45 cases in the intervention group
Control group The chemotherapy was strictly followed by the drug use routine administered by central vein paclitaxel and platinum administration rate were set at 180mlh and routine health guidance was given before and after chemotherapy
Intervention group In addition to the usual nursing measures of the control group traditional Chinese medicine hot bao acupoint treatment and home care were used
Patients in both the intervention and control groups were assessed for peripheral neuropathy on the 14th day after the completion of each two rounds of chemotherapy and the NCI-CTCAE FACTGOG-Ntx and KPSS score scales were assigned according to the patient-reported outcomes
Control group The chemotherapy was strictly followed by the drug use routine administered by central vein paclitaxel and platinum administration rate were set at 180mlh and routine health guidance was given before and after chemotherapy
Intervention group In addition to the usual nursing measures of the control group traditional Chinese medicine hot bao acupoint treatment and home care were used
Patients in both the intervention and control groups were assessed for peripheral neuropathy on the 14th day after the completion of each two rounds of chemotherapy and the NCI-CTCAE FACTGOG-Ntx and KPSS score scales were assigned according to the patient-reported outcomes
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