Breast Cancer Patients, Chemotherapy Induced Peripheral Neuropathy (CIPN), Paclitaxel-induced Peripheral Neuropathy
Conditions
Keywords
Chemotherapy-Induced Peripheral Neuropathy, Cold Salt Water, Foot Bath, Breast Cancer, Paclitaxel
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.
Interventions
OTHERCold salt water foot bath
The application of 175 grams of salt to cold water at a constant 22 degrees
OTHERCold water foot bath
Constant 22 degree cold water application
Sponsors
Tuba Eryiğit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled prospective study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To prevent the development of chemotherapy-associated peripheral neuropathy in patients | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTTuba Eryigit, PhD student
Outcome results
None listed