Clinical trial NCT06964802: The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy
Official title: The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Patients
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Paclitaxel-induced Peripheral Neuropathy
Keywords: Chemotherapy-Induced Peripheral Neuropathy
Cold Salt Water
Foot Bath
Breast Cancer
Paclitaxel
Lead sponsor: Istanbul Topkapi University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled prospective study
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: To prevent the development of chemotherapy-associated peripheral neuropathy in patients
timeFrame: This was at the end of the 12th week of paclitaxel treatment.
Secondary outcomes:
measure: 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.
timeFrame: This was at the end of the 12th week of paclitaxel treatment.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haydarpaşa Numune Training and Research Hospital
state: Uskudar
Study officials:
References: