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.
Women aged 18 and over.
Conscious
Speaking and understanding Turkish
The diagnosis was breast cancer
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
Parallel
Cold salt water foot bath
Other interventionThe application of 175 grams of salt to cold water at a constant 22 degrees
Cold water foot bath
Other interventionConstant 22 degree cold water application
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.
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.
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Tuba Eryiğit
Lead sponsor
Istanbul Topkapi University
Sponsor institution
