Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904340
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-15
First Post:
2023-05-13
Brief Title:
Transcutaneous Electrical Acupoint Stimulation on Symptoms Associated With Chemotherapy Induced Peripheral Neuropathy
Sponsor:
National Taipei University of Nursing and Health Sciences
Organization:
National Taipei University of Nursing and Health Sciences
Study Overview
Official Title:
The Efficacy of Social Media Assisted Home-based Transcutaneous Electrical Acupoint Stimulation on Symptoms Associated With Chemotherapy Induced Peripheral Neuropathy in Patients With Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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:
Breast cancer ranks first in Taiwans top ten gynecological cancers Chemotherapy is a standard treatment method for colorectal cancer and breast cancer but while destroying cancer cells it also destroys healthy cells resulting in side effects Peripheral neuropathy can lead to peripheral nerve damage and decreased activity which affects the patients quality of life Currently there is no standard and effective method for treating peripheral neuropathy caused by chemotherapy Therefore the purpose of this study is to investigate the effect of percutaneous electrical acupoint stimulation on improving peripheral nerve symptoms in breast cancer patients undergoing chemotherapy
Detailed Description:
Breast cancer ranks first in Taiwans top ten gynecological cancers Chemotherapy is a standard treatment method for colorectal cancer and breast cancer but while destroying cancer cells it also destroys healthy cells resulting in side effects Peripheral neuropathy can lead to peripheral nerve damage and decreased activity which affects the patients quality of life Currently there is no standard and effective method for treating peripheral neuropathy caused by chemotherapy Therefore the purpose of this study is to investigate the effect of percutaneous electrical acupoint stimulation on improving peripheral nerve symptoms in breast cancer patients undergoing chemotherapy An experimental study design will be adopted A convenient sample of 86 patients with breast cancer who completed the chemotherapy course within one month will be recruited from outpatient clinics of a medical center in the middle district of Taiwan Patients who are eligible and agree to participate will be randomly assigned to the transcutaneous electrical acupoint stimulation group or the control group The transcutaneous electrical acupoint stimulation group will receive 4 weeks of transcutaneous electrical acupoint stimulation intervention while the control group will not receive any measures related to this study Data from both groups will be collected at the time of admission the 1st week the 2nd week the 3rd week and the 4th week The study instruments include the cancer treatment-related quality of life neurotoxicity assessment subscale Total Neuropathy Score clinical version Brief Pain Inventory interference items scores and hand and foot pain Numerical Rating Scale The obtained data will be statistically analyzed using SPSS software The baseline equilibrium of the subjects demographic and disease characteristics will be examined by the Chi-square test and independent sample T-test For the main outcome variable Neurotoxicity Subscale and the Numerical Rating Scale for Hand and Foot Pain generalized estimating equations were used to analyze the effects of between-group time-to-group and time-interaction effects One-way analysis of variance The Analysis of Variance ANOVA to examine intra- and inter-group differences between the clinical version of the Integrated Neuropathy Score and the Simple Pain Scale Interference Item score pretest and posttest week 4
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