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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 EryiÄŸit. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Cold salt water foot bath group) | Experimental | During the three hours of paclitaxel treatment, 30 minutes of salt cold water foot bath application four times as 10 minutes break Patients will be evaluated with Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT) before the following chemotherapy cycle after the application of salt cold water foot bath during each cycle. These evaluations will be completed after 12 cycles and patients will be evaluated with CTCAE v5.0 and CIPNAT for a total of 12 times. In addition, all patients will be evaluated with vibration and monofilament test at the end of the 12th cycle. |
|
| Group B (Cold unsalted water foot bath group) | Active Comparator | During the three hours of paclitaxel treatment, 30 minutes unsalted cold water foot bath application four times as 10 minutes break Patients will be evaluated with Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT) before the following chemotherapy cycle after the application of unsalted cold water foot bath during each cycle. These evaluations will be completed after 12 cycles and patients will be evaluated with CTCAE v5.0 and CIPNAT for a total of 12 times. In addition, all patients will be evaluated with vibration and monofilament test at the end of the 12th cycle. |
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| Group C (control group) | No Intervention | Patients in this group will be given general information about the care guidelines for chemotherapy patients at the clinic where they receive treatment. This information will be provided once. At the end of the study, patients in the control group will be offered a choice of two application methods, and the method they choose will be applied to them in the same way as to Groups A and B. Group C patients will be evaluated with Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0) and Chemotherapy Induced Peripheral Neuropathy Assessment Tool (CIPNAT) before each chemotherapy cycle at the same time with Group A and B patients. In addition, all patients will be evaluated with vibration and monofilament test at the end of the 12th cycle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold salt water foot bath | Other | The application of 175 grams of salt to cold water at a constant 22 degrees |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This was at the end of the 12th week of paclitaxel treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tuba Eryigit, PhD student | Contact | +905059683332 | tubaeryigit@topkapi.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haydarpaşa Numune Training and Research Hospital | Recruiting | Istanbul | Uskudar | 34668 | Turkey (Türkiye) |
All participant responses and personal information will be used for scientific purposes only.
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Randomized controlled prospective study
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| Cold water foot bath | Other | Constant 22 degree cold water application |
|
| This was at the end of the 12th week of paclitaxel treatment. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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