Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352567
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-29
Brief Title:
Symptoms Associated With Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
Izmir Bakircay University
Organization:
Izmir Bakircay University
Study Overview
Official Title:
A View Of Perceived Symptoms Associated With Chemotherapy-Induced Peripheral Neuropathy In Patients With Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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 remains the most frequent type of cancer globally Nevertheless the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment Chemotherapy-induced peripheral neuropathy CIPN is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail Therefore in this cross-sectional study it was aimed to assess the potential symptoms associated with CIPN of patients with breast cancer who underwent systemic chemotherapy In addition it was aimed to assess the potential associations between experienced symptoms of CIPN and sociodemographic age body mass index etc and clinical features mean exposed dose type of surgery if any etc
Detailed Description:
Patients with breast cancer who underwent systemic chemotherapy were assessed with the European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy EORTC-CIPN20 questionnaire within 1-2 months after completion of systemic chemotherapy A simple data form was implemented in which patients age weight height marital status smoking status etc were investigated In addition the dose of the exposure of systemic chemotherapy was calculated according to the Body Surface Area BSA and DuBois formulation as follows BSA m2 Weight kg0425 height cm0725 0007184 The universal dose calculations were used to calculate the mean exposure according to the following doses for each patient-specific to their chemotherapy regimen Four cycles of Anthracycline were applied 14 days apart 60 mgm2 intravenous IV 12 cycles of Paclitaxel were applied seven days apart 80 mgm2 IV and four cycles of Docetaxel were applied 21 days apart 75 mgm2 IV
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