NCT06964802 The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy
| NCT ID | NCT06964802 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tuba Eryiğit |
| Condition | Breast Cancer Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-06-01 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06964802 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06964802 currently recruiting?
Yes, NCT06964802 is actively recruiting participants. Contact the research team at tubaeryigit@topkapi.edu.tr for enrollment information.
Where is the NCT06964802 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06964802 clinical trial?
NCT06964802 is sponsored by Tuba Eryiğit. The trial plans to enroll 30 participants.
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