Breast CancerNCT07817979
TENS, Compression, and Cryotherapy for Paclitaxel-Induced Peripheral Neuropathy in Women With Breast Cancer
A study testing Transcutaneous Electrical Nerve Stimulation, Cryotherapy and Compression Therapy in people with Breast Cancer and Chemotherapy-Induced Peripheral Neuropathy, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
This single-center, four-arm, parallel-group randomized controlled trial evaluates transcutaneous electrical nerve stimulation (TENS), compression, and cryotherapy for the management of chemotherapy-induced peripheral neuropathy (CIPN) in women with breast cancer receiving weekly adjuvant paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy-Induced Peripheral Neuropathy
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation, Cryotherapy and Compression Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2025to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Female and 18 years of age or older.
- Diagnosed with early-stage or locally advanced breast cancer.
- Receiving 12 weeks of weekly paclitaxel as adjuvant treatment.
- Clinically confirmed National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Grade 2 peripheral sensory neuropathy during the third week of paclitaxel treatment, before the third weekly infusion and randomization.
- Eastern Cooperative Oncology Group performance status of 0-2 and Karnofsky Performance Status greater than 70.
- Able to communicate and complete the study procedures.
- Provided written informed consent to participate.
Who cannot join
- Peripheral neuropathy present before initiation of paclitaxel treatment.
- Diabetic neuropathy or another neurological disorder that could affect the assessment of peripheral neuropathy.
- Receiving paclitaxel as neoadjuvant, metastatic, or palliative treatment.
- Cardiac pacemaker or another implanted electronic device contraindicating transcutaneous electrical nerve stimulation.
- Active infection, open wound, serious skin lesion, or clinically significant peripheral circulatory impairment in the upper or lower extremities where the interventions would be applied.
- Raynaud phenomenon, cryoglobulinemia, cold urticaria, or another clinical condition contraindicating cryotherapy.
- Regularly receiving another physical intervention for chemotherapy-induced peripheral neuropathy outside the study at enrollment or planning to receive such an intervention during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcutaneous Electrical Nerve Stimulation, Compression, and Cryotherapy on Chemotherapy-Induced Peripheral Neuropathy and Quality of Life in Women With Breast Cancer Receiving Weekly Adjuvant Paclitaxel: A Four-Arm Randomized Controlled Trial
This single-center, four-arm, parallel-group randomized controlled trial evaluates transcutaneous electrical nerve stimulation (TENS), compression, and cryotherapy for the management of chemotherapy-induced peripheral neuropathy (CIPN) in women with breast cancer receiving weekly adjuvant paclitaxel. A total of 140 participants with NCI-CTCAE Version 5.0 Grade 2 peripheral sensory neuropathy before the third weekly paclitaxel infusion were randomized in a 1:1:1:1 ratio to TENS, compression, cryotherapy, or routine care. The interventions were administered during weekly paclitaxel sessions from weeks 3 through 12. Outcomes were assessed at baseline before the third weekly infusion and before the sixth, ninth, and twelfth weekly infusions. The primary outcome is the EORTC QLQ-CIPN20 total score during the treatment period.
Read the detailed description
Chemotherapy-induced peripheral neuropathy is a clinically important and potentially dose-limiting adverse effect of paclitaxel. Most previous studies of cryotherapy and compression initiated these interventions before neuropathy developed and primarily evaluated prevention. This study evaluated transcutaneous electrical nerve stimulation (TENS), compression therapy, and cryotherapy when initiated after Grade 2 peripheral sensory neuropathy had developed during ongoing weekly paclitaxel treatment.
Women aged 18 years or older with early-stage or locally advanced breast cancer receiving 12 weeks of weekly adjuvant paclitaxel were assessed for eligibility before the third weekly infusion. Participants with NCI-CTCAE Version 5.0 Grade 2 peripheral sensory neuropathy who met all other eligibility criteria and provided written informed consent were randomized in a 1:1:1:1 ratio to four parallel groups: TENS, compression therapy, cryotherapy, or routine care. Randomization was stratified by age and implemented using computer-generated blocks of four with allocation concealment.
The active interventions were initiated during the third weekly paclitaxel session and administered once weekly through week 12, for a total of 10 planned sessions. Each active intervention was administered for 120 minutes, beginning 30 minutes before the paclitaxel infusion, continuing throughout the 60-minute infusion, and ending 30 minutes after infusion completion. The control group received routine oncological care and monitoring.
Because TENS, compression therapy, and cryotherapy were visible and physically perceptible, the study was conducted as an open-label trial. Participants, the intervention provider, the outcome assessor, and the analyst were aware of group assignments. Patient-reported outcomes were completed by participants who knew their assigned groups. NCI-CTCAE peripheral sensory neuropathy grading and the clinical examination components of the DN4 were performed before the weekly paclitaxel infusion and study intervention using standardized assessment procedures.
Assessments were performed at baseline before randomization, the third weekly paclitaxel infusion, and the first study intervention; before the sixth and ninth weekly infusions; and before the twelfth weekly infusion. The primary outcome was the baseline-adjusted treatment-period trajectory of the EORTC QLQ-CIPN20 total score. Secondary outcomes included the DN4 total score, EORTC QLQ-C30 Global Health Status/Quality of Life score, and NCI-CTCAE peripheral sensory neuropathy grade. The EORTC QLQ-CIPN20 sensory, motor, and autonomic subscale scores were evaluated as other pre-specified supportive outcomes.
- Being tested
- Transcutaneous Electrical Nerve Stimulation, Cryotherapy, Compression Therapy
- Keywords
- nursing, breast cancer, electrostimülation, compression therapy, cryotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
Conventional high-frequency transcutaneous electrical nerve stimulation (TENS) was administered once weekly from the third through the twelfth weekly paclitaxel infusion, for a total of 10 planned sessions. TENS was delivered using a dual-channel, battery-powered portable digital Bosch TENS device and four self-adhesive hypoallergenic surface electrodes. Electrodes were placed bilaterally over the PC6 region on the inner wrists and on the soles of the feet. The device was set to a frequency of 80 Hz and a pulse duration of 200-250 microseconds. Current intensity was increased gradually to produce a strong but comfortable tingling sensation without pain or visible muscle contraction, typically 10-30 mA and up to 60 mA according to participant tolerance. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion.
CryotherapyOther
Bilateral local cryotherapy was administered once weekly from the third through the twelfth weekly paclitaxel infusion, for a total of 10 planned sessions. Cryotherapy was applied to both hands and feet using glycerin-containing DETAMED Coolcare Chemotherapy Neuropathy Set cooling gel gloves and socks that completely covered the distal extremities and remained flexible when frozen. The gel gloves and socks were stored for at least 3 hours before each application in a freezer maintained at -20°C to -30°C. Cotton liners were worn under the gloves and socks, and the cooling sets were replaced at standardized intervals. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. Skin condition, peripheral circulation, and participant tolerance were monitored throughout each session.
Compression TherapyOther
Compression therapy was administered once weekly from the third through the twelfth weekly paclitaxel infusion, for a total of 10 planned sessions. For the lower extremities, bilateral Varimed CCL II knee-high graduated compression stockings were selected according to each participant's ankle and calf measurements. The stockings provided 23-32 mmHg pressure at the ankle, with pressure decreasing gradually toward the calf. For the upper extremities, each participant's standard glove size was determined by hand measurement, and two layers of Beybi Gloves surgical gloves one size smaller were applied bilaterally. Hand pressure was not measured directly; application was standardized using the same sizing procedure and double-glove technique. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. Fit, skin condition, peripheral circulation, and participant tolerance were monitored throughout each session.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Experimental | Participants randomized to this arm received transcutaneous electrical nerve stimulation (TENS) once weekly during weekly paclitaxel sessions from week 3 through week 12, for a total of 10 planned sessions. TENS was delivered using a dual-channel, battery-powered portable digital Bosch TENS device and four self-adhesive hypoallergenic surface electrodes (5 × 5 cm or 5 × 9 cm, as appropriate). Electrodes were placed bilaterally over the PC6 region on the inner wrists and on the soles of the feet. Conventional high-frequency TENS was administered at 80 Hz with a pulse duration of 200-250 microseconds. Intensity was increased to produce a strong but comfortable tingling sensation without pain or visible muscle contraction, typically 10-30 mA and up to 60 mA according to tolerance. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. Receives: Device: Transcutaneous Electrical Nerve Stimulation |
| Compression Therapy | Experimental | Participants randomized to this arm received compression therapy once weekly during weekly paclitaxel sessions from week 3 through week 12, for a total of 10 planned sessions. For the lower extremities, bilateral Varimed CCL II knee-high graduated compression stockings were selected according to ankle and calf measurements. The stockings provided 23-32 mmHg pressure at the ankle, with pressure decreasing gradually toward the calf. For the upper extremities, each participant's standard glove size was determined by hand measurement, and two layers of Beybi Gloves surgical gloves one size smaller were applied bilaterally. Hand pressure was not measured directly; the application was standardized using the same sizing procedure and double-glove technique. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. Receives: Other: Compression Therapy |
| Cryotherapy | Experimental | Participants randomized to this arm received bilateral local cryotherapy once weekly during weekly paclitaxel sessions from week 3 through week 12, for a total of 10 planned sessions. Cryotherapy was applied to both hands and feet using glycerin-containing DETAMED Coolcare Chemotherapy Neuropathy Set cooling gel gloves and socks that completely covered the distal extremities and remained flexible when frozen. The gel gloves and socks were stored for at least 3 hours before each application in a freezer maintained at -20°C to -30°C. Cotton liners were worn under the gloves and socks, and the cooling sets were replaced at standardized intervals. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. Skin condition, peripheral circulation, and participant tolerance were monitored throughout each session.Cotton liners were worn under the gloves and socks, and the cooling sets were replaced every 30 minutes to maintain the cooli Receives: Other: Cryotherapy |
| Routine Care Control | No intervention | Participants randomized to this arm received routine oncological care and monitoring throughout the study and did not receive TENS, compression therapy, or cryotherapy. Routine care included clinical assessment before each weekly paclitaxel infusion, monitoring of treatment-related toxicities, standard patient education on recognizing and reporting chemotherapy-induced peripheral neuropathy symptoms, and pharmacological or supportive treatment prescribed by the responsible medical oncologist when clinically indicated. Routine nursing and medical care was provided by the same chemotherapy unit team regardless of randomized group. EORTC QLQ-CIPN20, DN4, NCI-CTCAE Version 5.0, and EORTC QLQ-C30 assessments were performed at the same time points as in the intervention arms: before the third, sixth, ninth, and twelfth weekly paclitaxel infusions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 Total Score
The EORTC QLQ-CIPN20 is a patient-reported questionnaire assessing chemotherapy-induced peripheral neuropathy symptoms experienced during the previous week. Item responses are used to calculate a total score that is linearly transformed to a 0-to-100 scale. Higher scores indicate greater peripheral neuropathy symptom burden. Follow-up scores at T1, T2, and T3 are evaluated jointly in a baseline-adjusted longitudinal model, with the T0 score included as the baseline covariate.
Measured: Baseline before the third weekly paclitaxel infusion and first study intervention, and before the sixth, ninth, and twelfth weekly infusions, approximately 3, 6, and 9 weeks after baseline
Secondary outcomes (3)
Douleur Neuropathique 4 Questions (DN4) Total Score
Neuropathic pain characteristics are assessed using the Douleur Neuropathique 4 Questions (DN4). The instrument includes seven participant-reported symptom items and three clinical examination items. Each item is scored as 0 when absent and 1 when present, producing a total score ranging from 0 to 10. Higher scores indicate a greater neuropathic pain burden. Follow-up scores at T1, T2, and T3 are evaluated using a baseline-adjusted longitudinal model, with the corresponding T0 DN4 total score included as the baseline covariate.
Measured: Baseline before the third weekly paclitaxel infusion and first study intervention, and before the sixth, ninth, and twelfth weekly infusions, approximately 3, 6, and 9 weeks after baseline
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Global Health Status/Quality of Life Score
Health-related quality of life is assessed using the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Version 3.0. The scale score is linearly transformed to a 0-to-100 scale. Higher scores indicate better global health status and quality of life. Follow-up scores at T1, T2, and T3 are evaluated using a baseline-adjusted longitudinal model, with the corresponding T0 score included as the baseline covariate.
Measured: Baseline before the third weekly paclitaxel infusion and first study intervention, and before the sixth, ninth, and twelfth weekly infusions, approximately 3, 6, and 9 weeks after baseline
Peripheral Sensory Neuropathy Grade Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Peripheral sensory neuropathy severity is rated by an outcome assessor using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0. The outcome assessor was not involved in randomization or intervention delivery but was aware of group assignments. Grade 1 indicates asymptomatic neuropathy, loss of deep tendon reflexes, or paresthesia; Grade 2 indicates moderate symptoms limiting instrumental activities of daily living; Grade 3 indicates severe symptoms limiting self-care activities of daily living; and Grade 4 indicates life-threatening consequences requiring urgent intervention. Higher grades indicate greater neuropathy severity. Grade 2 peripheral sensory neuropathy at baseline was an eligibility criterion.
Measured: Baseline before the third weekly paclitaxel infusion and first study intervention, and before the sixth, ninth, and twelfth weekly infusions, approximately 3, 6, and 9 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start27 Apr 2025
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1:1:1 ratio to four parallel groups: transcutaneous electrical nerve stimulation, compression, cryotherapy, or routine care.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevcan Özkan, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817979
- Sponsor's protocol ID
- CumhuriyetU-SBE-SÖ-2
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual participant data will not be shared because external data sharing was not specified in the approved study protocol or participant informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation, Compression, and Cryotherapy on Chemotherapy-Induced Peripheral Neuropathy and Quality of Life in Women With Breast Cancer Receiving Weekly Adjuvant Paclitaxel: A Four-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07817979
- Acronym / sponsor ID
- CumhuriyetU-SBE-SÖ-2
- Keywords
- nursing, breast cancer, electrostimülation, compression therapy, cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 27 Apr 2025 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 14 Sep 2026 (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 single-center, four-arm, parallel-group randomized controlled trial evaluates transcutaneous electrical nerve stimulation (TENS), compression, and cryotherapy for the management of chemotherapy-induced peripheral neuropathy (CIPN) in women with breast cancer receiving weekly adjuvant paclitaxel. A total of 140 participants with NCI-CTCAE Version 5.0 Grade 2 peripheral sensory neuropathy before the third weekly paclitaxel infusion were randomized in a 1:1:1:1 ratio to TENS, compression, cryotherapy, or routine care. The interventions were administered during weekly paclitaxel sessions from weeks 3 through 12. Outcomes were assessed at baseline before the third weekly infusion and before the sixth, ninth, and twelfth weekly infusions. The primary outcome is the EORTC QLQ-CIPN20 total score during the treatment period.
Detailed description
Chemotherapy-induced peripheral neuropathy is a clinically important and potentially dose-limiting adverse effect of paclitaxel. Most previous studies of cryotherapy and compression initiated these interventions before neuropathy developed and primarily evaluated prevention. This study evaluated transcutaneous electrical nerve stimulation (TENS), compression therapy, and cryotherapy when initiated after Grade 2 peripheral sensory neuropathy had developed during ongoing weekly paclitaxel treatment.
Women aged 18 years or older with early-stage or locally advanced breast cancer receiving 12 weeks of weekly adjuvant paclitaxel were assessed for eligibility before the third weekly infusion. Participants with NCI-CTCAE Version 5.0 Grade 2 peripheral sensory neuropathy who met all other eligibility criteria and provided written informed consent were randomized in a 1:1:1:1 ratio to four parallel groups: TENS, compression therapy, cryotherapy, or routine care. Randomization was stratified by age and implemented using computer-generated blocks of four with allocation concealment.
The active interventions were initiated during the third weekly paclitaxel session and administered once weekly through week 12, for a total of 10 planned sessions. Each active intervention was administered for 120 minutes, beginning 30 minutes before the paclitaxel infusion, continuing throughout the 60-minute infusion, and ending 30 minutes after infusion completion. The control group received routine oncological care and monitoring.
Because TENS, compression therapy, and cryotherapy were visible and physically perceptible, the study was conducted as an open-label trial. Participants, the intervention provider, the outcome assessor, and the analyst were aware of group assignments. Patient-reported outcomes were completed by participants who knew their assigned groups. NCI-CTCAE peripheral sensory neuropathy grading and the clinical examination components of the DN4 were performed before the weekly paclitaxel infusion and study intervention using standardized assessment procedures.
Assessments were performed at baseline before randomization, the third weekly paclitaxel infusion, and the first study intervention; before the sixth and ninth weekly infusions; and before the twelfth weekly infusion. The primary outcome was the baseline-adjusted treatment-period trajectory of the EORTC QLQ-CIPN20 total score. Secondary outcomes included the DN4 total score, EORTC QLQ-C30 Global Health Status/Quality of Life score, and NCI-CTCAE peripheral sensory neuropathy grade. The EORTC QLQ-CIPN20 sensory, motor, and autonomic subscale scores were evaluated as other pre-specified supportive outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants were randomized in a 1:1:1:1 ratio to four parallel groups: transcutaneous electrical nerve stimulation, compression, cryotherapy, or routine care.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Experimental | Device: Transcutaneous Electrical Nerve StimulationParticipants randomized to this arm received transcutaneous electrical nerve stimulation (TENS) once weekly during weekly paclitaxel sessions from week 3 through week 12, for a total of 10 planned sessions. TENS was delivered using a dual-channel, battery-powered portable digital Bosch TENS device and four self-adhesive hypoallergenic surface electrodes (5 × 5 cm or 5 × 9 cm, as appropriate). Electrodes were placed bilaterally over the PC6 region on the inner wrists and on the soles of the feet. Conventional high-frequency TENS was administered at 80 Hz with a pulse duration of 200-250 microseconds. Intensity was increased to produce a strong but comfortable tingling sensation without pain or visible muscle contraction, typically 10-30 mA and up to 60 mA according to tolerance. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. |
| Compression Therapy | Experimental | Other: Compression TherapyParticipants randomized to this arm received compression therapy once weekly during weekly paclitaxel sessions from week 3 through week 12, for a total of 10 planned sessions. For the lower extremities, bilateral Varimed CCL II knee-high graduated compression stockings were selected according to ankle and calf measurements. The stockings provided 23-32 mmHg pressure at the ankle, with pressure decreasing gradually toward the calf. For the upper extremities, each participant's standard glove size was determined by hand measurement, and two layers of Beybi Gloves surgical gloves one size smaller were applied bilaterally. Hand pressure was not measured directly; the application was standardized using the same sizing procedure and double-glove technique. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. |
| Cryotherapy | Experimental | Other: CryotherapyParticipants randomized to this arm received bilateral local cryotherapy once weekly during weekly paclitaxel sessions from week 3 through week 12, for a total of 10 planned sessions. Cryotherapy was applied to both hands and feet using glycerin-containing DETAMED Coolcare Chemotherapy Neuropathy Set cooling gel gloves and socks that completely covered the distal extremities and remained flexible when frozen. The gel gloves and socks were stored for at least 3 hours before each application in a freezer maintained at -20°C to -30°C. Cotton liners were worn under the gloves and socks, and the cooling sets were replaced at standardized intervals. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. Skin condition, peripheral circulation, and participant tolerance were monitored throughout each session.Cotton liners were worn under the gloves and socks, and the cooling sets were replaced every 30 minutes to maintain the cooli |
| Routine Care Control | No intervention | –Participants randomized to this arm received routine oncological care and monitoring throughout the study and did not receive TENS, compression therapy, or cryotherapy. Routine care included clinical assessment before each weekly paclitaxel infusion, monitoring of treatment-related toxicities, standard patient education on recognizing and reporting chemotherapy-induced peripheral neuropathy symptoms, and pharmacological or supportive treatment prescribed by the responsible medical oncologist when clinically indicated. Routine nursing and medical care was provided by the same chemotherapy unit team regardless of randomized group. EORTC QLQ-CIPN20, DN4, NCI-CTCAE Version 5.0, and EORTC QLQ-C30 assessments were performed at the same time points as in the intervention arms: before the third, sixth, ninth, and twelfth weekly paclitaxel infusions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female and 18 years of age or older.
- Diagnosed with early-stage or locally advanced breast cancer.
- Receiving 12 weeks of weekly paclitaxel as adjuvant treatment.
- Clinically confirmed National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Grade 2 peripheral sensory neuropathy during the third week of paclitaxel treatment, before the third weekly infusion and randomization.
- Eastern Cooperative Oncology Group performance status of 0-2 and Karnofsky Performance Status greater than 70.
Key exclusion criteria (7 listed)
- Peripheral neuropathy present before initiation of paclitaxel treatment.
- Diabetic neuropathy or another neurological disorder that could affect the assessment of peripheral neuropathy.
- Receiving paclitaxel as neoadjuvant, metastatic, or palliative treatment.
- Cardiac pacemaker or another implanted electronic device contraindicating transcutaneous electrical nerve stimulation.
- Active infection, open wound, serious skin lesion, or clinically significant peripheral circulatory impairment in the upper or lower extremities where the interventions would be applied.
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 |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationConventional high-frequency transcutaneous electrical nerve stimulation (TENS) was administered once weekly from the third through the twelfth weekly paclitaxel infusion, for a total of 10 planned sessions. TENS was delivered using a dual-channel, battery-powered portable digital Bosch TENS device and four self-adhesive hypoallergenic surface electrodes. Electrodes were placed bilaterally over the PC6 region on the inner wrists and on the soles of the feet. The device was set to a frequency of 80 Hz and a pulse duration of 200-250 microseconds. Current intensity was increased gradually to produce a strong but comfortable tingling sensation without pain or visible muscle contraction, typically 10-30 mA and up to 60 mA according to participant tolerance. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. | Device | Transcutaneous Electrical Nerve Stimulation (TENS) |
| CryotherapyBilateral local cryotherapy was administered once weekly from the third through the twelfth weekly paclitaxel infusion, for a total of 10 planned sessions. Cryotherapy was applied to both hands and feet using glycerin-containing DETAMED Coolcare Chemotherapy Neuropathy Set cooling gel gloves and socks that completely covered the distal extremities and remained flexible when frozen. The gel gloves and socks were stored for at least 3 hours before each application in a freezer maintained at -20°C to -30°C. Cotton liners were worn under the gloves and socks, and the cooling sets were replaced at standardized intervals. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. Skin condition, peripheral circulation, and participant tolerance were monitored throughout each session. | Other | Cryotherapy |
| Compression TherapyCompression therapy was administered once weekly from the third through the twelfth weekly paclitaxel infusion, for a total of 10 planned sessions. For the lower extremities, bilateral Varimed CCL II knee-high graduated compression stockings were selected according to each participant's ankle and calf measurements. The stockings provided 23-32 mmHg pressure at the ankle, with pressure decreasing gradually toward the calf. For the upper extremities, each participant's standard glove size was determined by hand measurement, and two layers of Beybi Gloves surgical gloves one size smaller were applied bilaterally. Hand pressure was not measured directly; application was standardized using the same sizing procedure and double-glove technique. Each session lasted 120 minutes: 30 minutes before, 60 minutes during, and 30 minutes after the paclitaxel infusion. Fit, skin condition, peripheral circulation, and participant tolerance were monitored throughout each session. | Other | Compression Therapy |
Primary outcome
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 Total Score
Time frame: Baseline before the third weekly paclitaxel infusion and first study intervention, and before the sixth, ninth, and twelfth weekly infusions, approximately 3, 6, and 9 weeks after baseline
The EORTC QLQ-CIPN20 is a patient-reported questionnaire assessing chemotherapy-induced peripheral neuropathy symptoms experienced during the previous week. Item responses are used to calculate a total score that is linearly transformed to a 0-to-100 scale. Higher scores indicate greater peripheral neuropathy symptom burden. Follow-up scores at T1, T2, and T3 are evaluated jointly in a baseline-adjusted longitudinal model, with the T0 score included as the baseline covariate.
3 secondary outcomes
Douleur Neuropathique 4 Questions (DN4) Total Score
Time frame: Baseline before the third weekly paclitaxel infusion and first study intervention, and before the sixth, ninth, and twelfth weekly infusions, approximately 3, 6, and 9 weeks after baseline
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Global Health Status/Quality of Life Score
Time frame: Baseline before the third weekly paclitaxel infusion and first study intervention, and before the sixth, ninth, and twelfth weekly infusions, approximately 3, 6, and 9 weeks after baseline
Peripheral Sensory Neuropathy Grade Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
Time frame: Baseline before the third weekly paclitaxel infusion and first study intervention, and before the sixth, ninth, and twelfth weekly infusions, approximately 3, 6, and 9 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. Deidentified individual participant data will not be shared because external data sharing was not specified in the approved study protocol or participant informed consent form.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation, Cryotherapy and Compression Therapy in people with Breast Cancer and Chemotherapy-Induced Peripheral Neuropathy, run by Cumhuriyet University 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 14 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 Total Score (time frame: Baseline before the third weekly paclitaxel infusion and first study intervention, and before the sixth, ninth, and twelfth weekly infusions, approximately 3, 6, and 9 weeks after baseline). 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 14 Sep 2026.