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NCT Number: NCT06964802

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Haydarpaşa Numune Training and Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayse Ozkaraman, Prof./Thesis supervisor

SUB_INVESTIGATOR

Caglar Unal, Associate professor

CONTACT

[email protected]

+90 544 689 41 39

Caglar Unal, Associate professor

PRINCIPAL_INVESTIGATOR

Tuba Eryigit, PhD student

CONTACT

[email protected]

+90 0505 968 33 32

Tuba Eryigit, PhD student/Specialist nurse

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold salt water foot bath

Other

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

Cold water foot bath

Other

Constant 22 degree cold water application

Primary outcomes

  1. To prevent the development of chemotherapy-associated peripheral neuropathy in patients

    Time frame: This was at the end of the 12th week of paclitaxel treatment.

    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.

Secondary outcomes

  1. 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.

    Time frame: This was at the end of the 12th week of paclitaxel treatment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tuba Eryigit, PhD student

CONTACT

[email protected]

+905059683332

Sponsors and collaborators

Lead sponsor

Tuba Eryiğit

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 9, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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