About this trial
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
Qualifiers
Women aged 18 and over.
Conscious
Speaking and understanding Turkish
The diagnosis was breast cancer
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cold salt water foot bath
- Cold water foot bath
Treatment groups
Sponsors and collaborators
Tuba Eryiğit
Lead sponsor
Istanbul Topkapi University
Sponsor institution