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

NCT ID: NCT06964802

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-02-01

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.

Conditions

Breast Cancer Patients; Chemotherapy Induced Peripheral Neuropathy (CIPN); Paclitaxel-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cold salt water foot bath

Intervention Type: OTHER

The application of 175 grams of salt to cold water at a constant 22 degrees

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.

Group Type: ACTIVE_COMPARATOR

Cold water foot bath

Intervention Type: OTHER

Constant 22 degree cold water application

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cold salt water foot bath

The application of 175 grams of salt to cold water at a constant 22 degrees

Intervention Type: OTHER

Cold water foot bath

Constant 22 degree cold water application

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tuba Eryiğit

OTHER

Sponsor Role: lead

Responsible Party

Tuba Eryiğit

Research assistant/Specialist nurse

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Haydarpaşa Numune Training and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Tuba Eryigit, PhD student

Role: CONTACT

tubaeryigit@topkapi.edu.tr

+905059683332

Facility Contacts

Caglar Unal, Associate professor

Role: primary

caglarunal5@gmail.com

+90 544 689 41 39

Tuba Eryigit, PhD student

Role: backup

tubaeryigit@topkapi.edu.tr

+90 0505 968 33 32

Other Identifiers

IstanbulTopkapiU

Identifier Type: -

Identifier Source: org_study_id