The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Patients; Chemotherapy Induced Peripheral Neuropathy (CIPN); Paclitaxel-induced Peripheral Neuropathy
• Intervention / Treatment: Other: Cold salt water foot bath; Other: Cold water foot bath

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tuba Eryigit, PhD student; Phone Number: +905059683332; Email: tubaeryigit@topkapi.edu.tr

Study Locations

• Turkey (Türkiye)
  • Uskudar
    • Istanbul, Uskudar, Turkey (Türkiye), 34668
      • Recruiting
      • Haydarpasa Numune Training and Research Hospital
      • Contact: Caglar Unal, Associate professor; Phone Number: +90 544 689 41 39; Email: caglarunal5@gmail.com
      • Contact: Tuba Eryigit, PhD student; Phone Number: +90 0505 968 33 32; Email: tubaeryigit@topkapi.edu.tr
      • Principal Investigator: Caglar Unal, Associate professor
      • Sub-Investigator: Tuba Eryigit, PhD student/Specialist nurse
      • Sub-Investigator: Ayse Ozkaraman, Prof./Thesis supervisor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women aged 18 and over.
• Conscious
• Speaking and understanding Turkish
• The diagnosis was breast cancer
• Those who will receive paclitaxel chemotherapy
• These are patients who answered 'no' to the 'A' section of the CIPNAT scale

Exclusion Criteria:

• Responding to the vibration test (if the practitioner does not feel the vibration when the patient says they feel the vibration, it means that neuropathy is present)
• Feeling pressure in one or none of the three areas on the plantar surface of the foot according to the monofilament test
• Previous chemotherapy-associated peripheral neuropathy
• Diagnosed with diabetes
• Open wounds or skin ulcers on the foot
• With peripheral and central nervous system disease
• Peripheral vascular disease,
• Patients with bone or soft tissue metastases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Cold salt water foot bath group); During the three hours of paclitaxel treatment, 30 minutes of salt cold water foot bath application four times as 10 minutes break Patients will be evaluated with Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT) before the following chemotherapy cycle after the application of salt cold water foot bath during each cycle. These evaluations will be completed after 12 cycles and patients will be evaluated with CTCAE v5.0 and CIPNAT for a total of 12 times. In addition, all patients will be evaluated with vibration and monofilament test at the end of the 12th cycle.	Other: Cold salt water foot bath; The application of 175 grams of salt to cold water at a constant 22 degrees
Active Comparator: Group B (Cold unsalted water foot bath group); During the three hours of paclitaxel treatment, 30 minutes unsalted cold water foot bath application four times as 10 minutes break Patients will be evaluated with Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT) before the following chemotherapy cycle after the application of unsalted cold water foot bath during each cycle. These evaluations will be completed after 12 cycles and patients will be evaluated with CTCAE v5.0 and CIPNAT for a total of 12 times. In addition, all patients will be evaluated with vibration and monofilament test at the end of the 12th cycle.	Other: Cold water foot bath; Constant 22 degree cold water application
No Intervention: Group C (control group); Patients in this group will be given general information about the care guidelines for chemotherapy patients at the clinic where they receive treatment. This information will be provided once. At the end of the study, patients in the control group will be offered a choice of two application methods, and the method they choose will be applied to them in the same way as to Groups A and B. Group C patients will be evaluated with Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT) before each chemotherapy cycle at the same time with Group A and B patients. In addition, all patients will be evaluated with vibration and monofilament test at the end of the 12th cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To prevent the development of chemotherapy-associated peripheral neuropathy in patients	Patients who respond 'No' to part A of the CIPNAT scale and who do not respond to the monofilament and vibration tests will be considered free of chemotherapy-related peripheral neuropathy.	This was at the end of the 12th week of paclitaxel treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
If you are experiencing chemotherapy-related peripheral neuropathy, the symptoms should be mild, occur less frequently and have a minimal impact on your daily life and activities.	A score close to 0 on the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) scale, which ranges from 0 to 140, and a grade close to 1 on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale, which grades from 1 to 5.	This was at the end of the 12th week of paclitaxel treatment.

Collaborators and Investigators

• Sponsor: Tuba Eryiğit

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): December 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 30, 2025
• First Posted (Actual): May 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Paclitaxel; Foot Bath; Chemotherapy-Induced Peripheral Neuropathy; Cold Salt Water
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: IstanbulTopkapiU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All participant responses and personal information will be used for scientific purposes only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No