Breast Cancer PatientsNCT06964802
The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy
A study testing Cold salt water foot bath and Cold water foot bath in people with Breast Cancer Patients and Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Tuba Eryiğit at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Patients, Chemotherapy Induced Peripheral Neuropathy (CIPN), Paclitaxel-induced Peripheral Neuropathy
- What is being tested?
- Cold salt water foot bath and Cold water foot bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Haydarpaşa Numune Training and Research Hospital
Istanbul, Uskudar, 34668
Caglar Unal, Associate professor, +90 544 689 41 39, caglarunal5@gmail.com
Tuba Eryigit, PhD student, +90 0505 968 33 32, tubaeryigit@topkapi.edu.tr
About this study
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):
Read more
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.
- Conditions
- Breast Cancer Patients, Chemotherapy Induced Peripheral Neuropathy (CIPN), Paclitaxel-induced Peripheral Neuropathy
- Being tested
- Cold salt water foot bath, Cold water foot bath
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy, Cold Salt Water, Foot Bath, Breast Cancer, Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold salt water foot bathOther
The application of 175 grams of salt to cold water at a constant 22 degrees
Cold water foot bathOther
Constant 22 degree cold water application
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cold salt water foot bath |
| 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. Receives: Other: Cold water foot bath |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This was at the end of the 12th week of paclitaxel treatment.
Secondary outcomes (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.
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.
Measured: This was at the end of the 12th week of paclitaxel treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Jun 2025
- Primary completion1 Dec 2025
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled prospective study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tuba Eryiğit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuba Eryiğit, Istanbul Topkapi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964802
- Sponsor's protocol ID
- IstanbulTopkapiU
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participant responses and personal information will be used for scientific purposes only.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Salt Water Foot Bath on the Development Of Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06964802
- Acronym / sponsor ID
- IstanbulTopkapiU
- Conditions
- Breast Cancer Patients, Chemotherapy Induced Peripheral Neuropathy (CIPN), Paclitaxel-induced Peripheral Neuropathy
- Keywords
- Chemotherapy-Induced Peripheral Neuropathy, Cold Salt Water, Foot Bath, Breast Cancer, Paclitaxel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tuba EryiğitUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled prospective study
| Arm | Type | Receives |
|---|---|---|
| Group A (Cold salt water foot bath group) | Experimental | Other: Cold salt water foot bathDuring 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 | Other: Cold water foot bathDuring 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 18 and over.
- Conscious
- Speaking and understanding Turkish
- The diagnosis was breast cancer
- Those who will receive paclitaxel chemotherapy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold salt water foot bathThe application of 175 grams of salt to cold water at a constant 22 degrees | Other | Group A (Cold salt water foot bath group) |
| Cold water foot bathConstant 22 degree cold water application | Other | Group B (Cold unsalted water foot bath group) |
Primary outcome
To prevent the development of chemotherapy-associated peripheral neuropathy in patients
Time frame: 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.
1 secondary outcome
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.
Time frame: This was at the end of the 12th week of paclitaxel treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. All participant responses and personal information will be used for scientific purposes only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold salt water foot bath and Cold water foot bath in people with Breast Cancer Patients and Chemotherapy Induced Peripheral Neuropathy (CIPN), run by Tuba Eryiğit at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuba Eryigit, PhD student (+905059683332, tubaeryigit@topkapi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To prevent the development of chemotherapy-associated peripheral neuropathy in patients (time frame: This was at the end of the 12th week of paclitaxel treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.