Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT06964802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
Tuba Eryiğit
Organization:
Study Overview
Official Title:
The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
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 prospective, randomised, controlled study was designed to evaluate the effectiveness of salt and unsalted cold water foot baths in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving paclitaxel. The study's sub-objectives were to minimise the development of CIPN, reduce its severity and incidence of symptoms, and minimise its impact on daily life and activities.
Hypothesis(es):
H1: Salt cold water foot bath affects the development of chemotherapy-induced peripheral neuropathy.
H2: There is an effect of unsalted cold water foot bath on the development of chemotherapy-induced peripheral neuropathy.
H3: The effects of salt and unsalted cold water foot baths on the development of chemotherapy-induced peripheral neuropathy.
H4: Salt and unsalted cold water foot baths are more effective than standard clinical care in the development of chemotherapy-induced peripheral neuropathy.
Researchers will compare the salt cold water with the unsalted cold water, unsalted cold water and control group to determine whether the salt cold water has an effect on CIPN.
The experimental group and active comparator participants will continue the application for 12 cycles (12 weeks) of paclitaxel. The application will be applied by researcher Tuba Eryiğit. In addition, before each application for 12 weeks, the severity of CIPN, its effect on daily life and grade will be evaluated.
The control group will continue clinical routine care applications for 12 cycles (12 weeks). In addition, the severity of CIPN, its effect on daily life and grade will be evaluated before each treatment in the same way as the experimental groups.
Hypothesis(es):
H1: Salt cold water foot bath affects the development of chemotherapy-induced peripheral neuropathy.
H2: There is an effect of unsalted cold water foot bath on the development of chemotherapy-induced peripheral neuropathy.
H3: The effects of salt and unsalted cold water foot baths on the development of chemotherapy-induced peripheral neuropathy.
H4: Salt and unsalted cold water foot baths are more effective than standard clinical care in the development of chemotherapy-induced peripheral neuropathy.
Researchers will compare the salt cold water with the unsalted cold water, unsalted cold water and control group to determine whether the salt cold water has an effect on CIPN.
The experimental group and active comparator participants will continue the application for 12 cycles (12 weeks) of paclitaxel. The application will be applied by researcher Tuba Eryiğit. In addition, before each application for 12 weeks, the severity of CIPN, its effect on daily life and grade will be evaluated.
The control group will continue clinical routine care applications for 12 cycles (12 weeks). In addition, the severity of CIPN, its effect on daily life and grade will be evaluated before each treatment in the same way as the experimental groups.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: