The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy

Обзор

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.

Вмешательства

• Другое Cold salt water foot bath
  The application of 175 grams of salt to cold water at a constant 22 degrees
• Другое Cold water foot bath
  Constant 22 degree cold water application

Первичные конечные точки

• To prevent the development of chemotherapy-associated peripheral neuropathy in patients [Срок оценки: This was at the end of the 12th week of paclitaxel treatment.]

Вторичные конечные точки (1)

• 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. [Срок оценки: This was at the end of the 12th week of paclitaxel treatment.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Haydarpaşa Numune Training and Research Hospital — Istanbul

Идентификаторы

NCT: NCT06964802 · IstanbulTopkapiU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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