Cold salt-water foot baths to prevent paclitaxel-related nerve damage

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

This study tests whether taking cold salt-water or plain cold-water foot baths during paclitaxel chemotherapy can prevent or reduce chemotherapy-related peripheral nerve damage in women with breast cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Istanbul Topkapi University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Istanbul, Uskudar)
• Trial ID: NCT06964802 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, controlled trial that assigns Turkish-speaking women with breast cancer receiving paclitaxel to cold salt-water foot baths, unsalted cold-water foot baths, or standard care. Interventions are delivered during chemotherapy and participants are monitored over time using neuropathy screening tools such as the CIPNAT scale, monofilament testing, and vibration testing to track onset, severity, and functional impact. The primary aims are to reduce the incidence and severity of chemotherapy-induced peripheral neuropathy and its effects on daily activities. Key exclusion criteria include preexisting neuropathy, diabetes, foot ulcers, peripheral vascular or nervous system disease, and bone or soft tissue metastases.

Who should consider this trial

Good fit: Women aged 18 or older with breast cancer who speak Turkish, are scheduled to receive paclitaxel, and have no baseline chemotherapy-associated neuropathy or diabetes are the intended participants.

Not a fit: Patients with preexisting peripheral neuropathy, diabetes, foot wounds, peripheral vascular or central nervous system disease, or bone/soft-tissue metastases are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, this low-cost, noninvasive approach could lower how often and how severely paclitaxel causes peripheral neuropathy and help patients keep better daily function.

How similar studies have performed: Related cryotherapy (frozen glove/boot) studies have shown some benefit in small trials, but the use of cold salt-water foot baths for CIPN prevention is relatively novel and not well established.

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

Where this trial is running

Istanbul, Uskudar

• Haydarpaşa Numune Training and Research Hospital — Istanbul, Uskudar, Turkey (Türkiye) (RECRUITING)

Study contacts

• Study coordinator: Tuba Eryigit, PhD student

Conditions: Breast Cancer Patients, Chemotherapy Induced Peripheral Neuropathy, Paclitaxel-induced Peripheral Neuropathy, Chemotherapy-Induced Peripheral Neuropathy, Cold Salt Water, Foot Bath, Breast Cancer, Paclitaxel