CIPN - Chemotherapy-Induced Peripheral NeuropathyNCT07409987
TENS and Compression for Established Oxaliplatin-Induced Peripheral Neuropathy
A study testing TENS, Compression Garments and Sequential TENS Plus Compression in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Gastrointestinal Cancers, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Chemotherapy-induced peripheral neuropathy is a clinically important adverse effect of oxaliplatin-based chemotherapy that may cause sensory symptoms, neuropathic pain, functional limitations, and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIPN - Chemotherapy-Induced Peripheral Neuropathy, Gastrointestinal Cancers
- What is being tested?
- TENS, Compression Garments and Sequential TENS Plus Compression
- 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
- 2 Aug 2024to 28 Jan 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Diagnosed with metastatic gastrointestinal cancer, including gastric, pancreatic, colon, or rectal cancer
- Scheduled to receive six cycles of oxaliplatin-based chemotherapy with FOLFOX or FOLFIRINOX
- Having received one cycle of oxaliplatin-based chemotherapy
- Having Grade 2 or higher chemotherapy-induced peripheral neuropathy according to NCI-CTCAE v5.0 before the Cycle 2 intervention
- Eastern Cooperative Oncology Group performance status of 0-2
- Having provided written informed consent to participate
Who cannot join
- Having a diagnosed psychiatric disorder that could interfere with informed consent, communication, or adherence to the study procedures
- Having a cardiac pacemaker or another implanted electronic device contraindicating TENS
- Having pre-existing peripheral neuropathy before the initiation of oxaliplatin-based chemotherapy or neuropathy attributable to another cause
- Having diabetes mellitus
- Having peripheral vascular disease or another clinically significant circulatory disorder affecting the hands or feet
- Having a skin lesion or other skin condition at the sites where TENS electrodes or compression garments would be applied
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University Health Services Application and Research Hospital
Sivas, Sivas, 58010
About this study
Official title: Comparative Effects of Transcutaneous Electrical Nerve Stimulation, Compression, and Sequential TENS Plus Compression on Established Oxaliplatin-Induced Peripheral Neuropathy in Patients With Metastatic Gastrointestinal Cancer: A Four-Arm Randomized Controlled Trial
Chemotherapy-induced peripheral neuropathy is a clinically important adverse effect of oxaliplatin-based chemotherapy that may cause sensory symptoms, neuropathic pain, functional limitations, and reduced quality of life. This randomized, open-label, four-arm parallel-group study evaluated the comparative effects of transcutaneous electrical nerve stimulation (TENS), compression, sequential TENS followed by compression, and usual care in 140 adults with metastatic gastrointestinal cancer who developed Grade 2 or higher chemotherapy-induced peripheral neuropathy after the first cycle of oxaliplatin-based chemotherapy. Participants were allocated in a 1:1:1:1 ratio.
The primary outcome was the EORTC QLQ-CIPN20 total score evaluated longitudinally across the post-baseline treatment-period assessments before Cycles 3-6, with the score obtained before Cycle 2 included as the baseline covariate. The overall Group×Time interaction represented the primary treatment effect, and the baseline-adjusted between-group comparison before Cycle 6 represented the primary endpoint comparison.
Secondary outcomes included the EORTC QLQ-CIPN20 sensory, motor, and autonomic domain scores; EORTC QLQ-C30 scale scores; DN4 total score and DN4-defined neuropathic pain positivity; and clinician-rated NCI-CTCAE v5.0 peripheral sensory neuropathy grade. A separate exploratory follow-up assessment was conducted 6 months after Cycle 6.
Read the detailed description
This randomized, open-label, four-arm parallel-group study evaluated supportive interventions for the management of established chemotherapy-induced peripheral neuropathy in patients receiving oxaliplatin-based chemotherapy. Eligible participants were adults with metastatic gastrointestinal cancer who had received one cycle of FOLFOX or FOLFIRINOX and had Grade 2 or higher peripheral sensory neuropathy according to NCI-CTCAE v5.0 before the Cycle 2 intervention.
A total of 140 participants were randomly allocated in a 1:1:1:1 ratio to TENS, compression, sequential TENS followed by compression, or usual care, with 35 participants in each group. Participants remained in their assigned parallel groups throughout the study. Intervention sessions were administered at 14-day intervals from Cycle 2 through Cycle 6, resulting in five sessions per participant.
The prespecified peri-infusion intervention window lasted 180 minutes, comprising 30 minutes before, 120 minutes during, and 30 minutes after the oxaliplatin infusion. In the TENS group, transcutaneous electrical nerve stimulation was administered throughout this 180-minute window. TENS was delivered using Program 4 of the F. Bosch FB2405 TENS+EMS device. Program 4 provided frequency- and pulse-width-modulated stimulation, with pulse rates ranging from 2 to 60 Hz and pulse widths ranging from 156 to 260 microseconds. The 40-Hz value informed the original intervention rationale; however, the actual stimulation was not a fixed 40-Hz, 100-microsecond output. Intensity was individually titrated to produce a strong but comfortable and non-painful sensory sensation without visible muscle contraction.
In the compression group, bilateral compression of the hands and feet was applied throughout the same 180-minute peri-infusion window. Surgical gloves one size smaller than each participant's individually determined size and Class II graduated compression stockings providing 23-32 mmHg were used.
Because no established combined TENS-plus-compression dosing protocol was available, participants in the sequential intervention group received 90 minutes of TENS followed by 90 minutes of compression within the same 180-minute peri-infusion window. TENS began 30 minutes before the oxaliplatin infusion and continued during the first 60 minutes of the 120-minute infusion. After TENS was discontinued and the electrodes were removed, compression was initiated and maintained during the remaining 60 minutes of the infusion and for 30 minutes after its completion. The usual-care control group received routine clinical care without a study-specific TENS or compression intervention.
Outcomes were assessed before Cycle 2 (T0), before Cycles 3-6 (T1-T4), and 6 months after completion of Cycle 6 (T5). The primary outcome was the EORTC QLQ-CIPN20 total score evaluated longitudinally across the post-baseline treatment-period assessments from T1 to T4, with the T0 score included as the baseline covariate. The overall Group-by-Time interaction represented the primary treatment effect. The set of baseline-adjusted planned between-group contrasts at T4 represented the primary endpoint pairwise comparisons.
Secondary treatment-period outcomes included the EORTC QLQ-CIPN20 sensory, motor, and autonomic domain scores; EORTC QLQ-C30 scale scores; clinician-rated NCI-CTCAE v5.0 peripheral sensory neuropathy grade; DN4 total score; and DN4-defined neuropathic pain positivity. The T5 assessments were treated as separate exploratory follow-up outcomes.
- Being tested
- TENS, Compression Garments, Sequential TENS Plus Compression
- Keywords
- Chemotherapy ınduced peripheral neuropathy, Nursing, compression, Oxaliplatin, Transcutaneous electrical nerve stimulation, Randomized controlled trial
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
TENS was delivered using the F. Bosch FB2405 TENS+EMS dual-channel device with four 5 × 5-cm surface electrodes placed bilaterally over PC6 and KI1. Program 4 provided a modulated pulse rate of 2-60 Hz and a pulse width of 156-260 microseconds. The device output was adjustable from 0-80 mA per channel into a 500-Ω load, but no fixed mA value was used. Intensity was individually titrated to a strong, comfortable, non-painful sensory level without visible muscle contraction. Each session lasted 180 minutes: 30 minutes before, throughout the 120-minute oxaliplatin infusion, and 30 minutes after the infusion. Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions.
Compression GarmentsDevice
Bilateral compression of the hands and feet was applied using Beybi Sensitive surgical gloves one size smaller than the participant's measured glove size and knee-high Varimed CCL II graduated compression stockings providing 23-32 mmHg. Each session lasted 180 minutes: 30 minutes before, throughout the 120-minute oxaliplatin infusion, and 30 minutes after the infusion. Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions. All applications were individually fitted and directly supervised by the same research nurse.
Sequential TENS Plus CompressionDevice
Participants received 90 minutes of TENS followed immediately by 90 minutes of bilateral hand-and-foot compression, using the same devices, parameters, electrode placement, gloves, and stockings as in the monotherapy groups. TENS began 30 minutes before the oxaliplatin infusion and continued during the first 60 minutes of the 120-minute infusion. After TENS was stopped and the electrodes were removed, compression was applied during the remaining 60 minutes of the infusion and for 30 minutes afterward. The total sequential intervention lasted 180 minutes. Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions.
| Study group | Role | What they receive |
|---|---|---|
| TENS Group | Experimental | Participants received the TENS intervention at each scheduled session from Cycle 2 through Cycle 6 during oxaliplatin-based chemotherapy, in addition to usual care. Receives: Device: TENS |
| Compression group | Experimental | Participants received the compression intervention at each scheduled session from Cycle 2 through Cycle 6 during oxaliplatin-based chemotherapy, in addition to usual care. Receives: Device: Compression Garments |
| Sequential TENS Plus Compression Group | Experimental | Participants received TENS followed by compression at each scheduled intervention session from Cycle 2 through Cycle 6 during oxaliplatin-based chemotherapy, in addition to usual care. Receives: Device: Sequential TENS Plus Compression |
| Usual Care Control Group | No intervention | Participants received usual care from Cycle 2 through Cycle 6 and received no study-specific TENS or compression intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline-Adjusted EORTC QLQ-CIPN20 Total Score Trajectory Across T1-T4
The EORTC QLQ-CIPN20 is a 20-item patient-reported questionnaire assessing sensory, motor, and autonomic symptoms associated with chemotherapy-induced peripheral neuropathy. Scores are linearly transformed to a 0-100 scale, with higher scores indicating greater CIPN-related symptom burden.
The primary outcome was the baseline-adjusted post-baseline trajectory of the EORTC QLQ-CIPN20 total score across T1-T4. The assessments before Cycles 3-6 (T1-T4) were modelled jointly, with the score obtained before Cycle 2 (T0) included as the baseline covariate. The overall Group-by-Time interaction constituted the primary treatment-effect test. Baseline-adjusted between-group contrasts at T4 constituted the primary endpoint pairwise comparisons.
Measured: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
Secondary outcomes (3)
Baseline-Adjusted EORTC QLQ-C30 Scale Score Trajectories Across T1-T4
The EORTC QLQ-C30 is a 30-item patient-reported questionnaire assessing health-related quality of life in patients with cancer. It includes five functional scales, three symptom scales, a global health status/quality-of-life scale, and six single-item symptom measures. Scores are linearly transformed to a 0-100 scale. Higher functional and global health status scores indicate better functioning and quality of life, whereas higher symptom scores indicate greater symptom burden.
For each EORTC QLQ-C30 scale, the assessments before Cycles 3-6 (T1-T4) were modelled jointly, with the corresponding score obtained before Cycle 2 (T0) included as the baseline covariate. The Group-by-Time interaction was evaluated as a secondary treatment-period effect.
Measured: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
NCI-CTCAE v5.0 Peripheral Sensory Neuropathy Grade Across T1-T4
Chemotherapy-induced peripheral sensory neuropathy severity was assessed by a medical oncologist using the clinician-rated National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0). Peripheral sensory neuropathy was graded from 0 to 4, with higher grades indicating greater severity and functional impairment.
Because all participants were classified as Grade 2 at T0 and sparse or zero cells prevented stable repeated-measures categorical modelling, grade distributions were compared among the randomized groups separately at each post-baseline treatment-period assessment from T1 to T4.
Measured: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
DN4 Total Score Trajectory and DN4-Defined Neuropathic Pain Positivity Across T1-T4
Neuropathic pain was assessed using the Douleur Neuropathique en 4 Questions (DN4), a 10-item clinician-administered instrument comprising seven symptom-interview items and three clinical-examination items. The total score ranges from 0 to 10, with higher scores indicating a greater number of neuropathic pain features. A score of 4 or higher was classified as DN4-defined neuropathic pain positivity.
The DN4 total scores obtained before Cycles 3-6 (T1-T4) were modelled jointly, with the DN4 total score obtained before Cycle 2 (T0) included as the baseline covariate. The Group-by-Time interaction was evaluated as a continuous secondary treatment-period effect. DN4-defined neuropathic pain positivity was compared among the randomized groups separately at each T1-T4 assessment.
Measured: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start2 Aug 2024
- Primary completion28 Jul 2025
- Study completion28 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies 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: usual care, compression, TENS, and sequential TENS followed by compression. Randomization was stratified by prespecified age categories (\<65 and \>=65 years) and sex. Within each stratum, a computer-generated fixed-block randomization sequence with a fixed block size of four was used. Each block contained one allocation to each of the four study groups, and the order of allocations was randomly permuted within each block. The allocation sequence was prepared and maintained by an independent oncology nurse. Participants remained in their originally assigned groups throughout the study.
- 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
- Investigators
- Şerife KARAGÖZOĞLU, Proff., Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409987
- Sponsor's protocol ID
- CumhuriyetU-SBE-SÖ-1
- Status last verified
- Aug 2026
- First submitted
- 31 Jan 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Transcutaneous Electrical Nerve Stimulation, Compression, and Sequential TENS Plus Compression on Established Oxaliplatin-Induced Peripheral Neuropathy in Patients With Metastatic Gastrointestinal Cancer: A Four-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07409987
- Acronym / sponsor ID
- CumhuriyetU-SBE-SÖ-1
- Keywords
- Chemotherapy ınduced peripheral neuropathy, Nursing, compression, Oxaliplatin, Transcutaneous electrical nerve stimulation, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 13 Feb 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.
Chemotherapy-induced peripheral neuropathy is a clinically important adverse effect of oxaliplatin-based chemotherapy that may cause sensory symptoms, neuropathic pain, functional limitations, and reduced quality of life. This randomized, open-label, four-arm parallel-group study evaluated the comparative effects of transcutaneous electrical nerve stimulation (TENS), compression, sequential TENS followed by compression, and usual care in 140 adults with metastatic gastrointestinal cancer who developed Grade 2 or higher chemotherapy-induced peripheral neuropathy after the first cycle of oxaliplatin-based chemotherapy. Participants were allocated in a 1:1:1:1 ratio.
The primary outcome was the EORTC QLQ-CIPN20 total score evaluated longitudinally across the post-baseline treatment-period assessments before Cycles 3-6, with the score obtained before Cycle 2 included as the baseline covariate. The overall Group×Time interaction represented the primary treatment effect, and the baseline-adjusted between-group comparison before Cycle 6 represented the primary endpoint comparison.
Secondary outcomes included the EORTC QLQ-CIPN20 sensory, motor, and autonomic domain scores; EORTC QLQ-C30 scale scores; DN4 total score and DN4-defined neuropathic pain positivity; and clinician-rated NCI-CTCAE v5.0 peripheral sensory neuropathy grade. A separate exploratory follow-up assessment was conducted 6 months after Cycle 6.
Detailed description
This randomized, open-label, four-arm parallel-group study evaluated supportive interventions for the management of established chemotherapy-induced peripheral neuropathy in patients receiving oxaliplatin-based chemotherapy. Eligible participants were adults with metastatic gastrointestinal cancer who had received one cycle of FOLFOX or FOLFIRINOX and had Grade 2 or higher peripheral sensory neuropathy according to NCI-CTCAE v5.0 before the Cycle 2 intervention.
A total of 140 participants were randomly allocated in a 1:1:1:1 ratio to TENS, compression, sequential TENS followed by compression, or usual care, with 35 participants in each group. Participants remained in their assigned parallel groups throughout the study. Intervention sessions were administered at 14-day intervals from Cycle 2 through Cycle 6, resulting in five sessions per participant.
The prespecified peri-infusion intervention window lasted 180 minutes, comprising 30 minutes before, 120 minutes during, and 30 minutes after the oxaliplatin infusion. In the TENS group, transcutaneous electrical nerve stimulation was administered throughout this 180-minute window. TENS was delivered using Program 4 of the F. Bosch FB2405 TENS+EMS device. Program 4 provided frequency- and pulse-width-modulated stimulation, with pulse rates ranging from 2 to 60 Hz and pulse widths ranging from 156 to 260 microseconds. The 40-Hz value informed the original intervention rationale; however, the actual stimulation was not a fixed 40-Hz, 100-microsecond output. Intensity was individually titrated to produce a strong but comfortable and non-painful sensory sensation without visible muscle contraction.
In the compression group, bilateral compression of the hands and feet was applied throughout the same 180-minute peri-infusion window. Surgical gloves one size smaller than each participant's individually determined size and Class II graduated compression stockings providing 23-32 mmHg were used.
Because no established combined TENS-plus-compression dosing protocol was available, participants in the sequential intervention group received 90 minutes of TENS followed by 90 minutes of compression within the same 180-minute peri-infusion window. TENS began 30 minutes before the oxaliplatin infusion and continued during the first 60 minutes of the 120-minute infusion. After TENS was discontinued and the electrodes were removed, compression was initiated and maintained during the remaining 60 minutes of the infusion and for 30 minutes after its completion. The usual-care control group received routine clinical care without a study-specific TENS or compression intervention.
Outcomes were assessed before Cycle 2 (T0), before Cycles 3-6 (T1-T4), and 6 months after completion of Cycle 6 (T5). The primary outcome was the EORTC QLQ-CIPN20 total score evaluated longitudinally across the post-baseline treatment-period assessments from T1 to T4, with the T0 score included as the baseline covariate. The overall Group-by-Time interaction represented the primary treatment effect. The set of baseline-adjusted planned between-group contrasts at T4 represented the primary endpoint pairwise comparisons.
Secondary treatment-period outcomes included the EORTC QLQ-CIPN20 sensory, motor, and autonomic domain scores; EORTC QLQ-C30 scale scores; clinician-rated NCI-CTCAE v5.0 peripheral sensory neuropathy grade; DN4 total score; and DN4-defined neuropathic pain positivity. The T5 assessments were treated as separate exploratory follow-up 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: usual care, compression, TENS, and sequential TENS followed by compression. Randomization was stratified by prespecified age categories (<65 and >=65 years) and sex. Within each stratum, a computer-generated fixed-block randomization sequence with a fixed block size of four was used. Each block contained one allocation to each of the four study groups, and the order of allocations was randomly permuted within each block. The allocation sequence was prepared and maintained by an independent oncology nurse. Participants remained in their originally assigned groups throughout the study.
| Arm | Type | Receives |
|---|---|---|
| TENS Group | Experimental | Device: TENSParticipants received the TENS intervention at each scheduled session from Cycle 2 through Cycle 6 during oxaliplatin-based chemotherapy, in addition to usual care. |
| Compression group | Experimental | Device: Compression GarmentsParticipants received the compression intervention at each scheduled session from Cycle 2 through Cycle 6 during oxaliplatin-based chemotherapy, in addition to usual care. |
| Sequential TENS Plus Compression Group | Experimental | Device: Sequential TENS Plus CompressionParticipants received TENS followed by compression at each scheduled intervention session from Cycle 2 through Cycle 6 during oxaliplatin-based chemotherapy, in addition to usual care. |
| Usual Care Control Group | No intervention | –Participants received usual care from Cycle 2 through Cycle 6 and received no study-specific TENS or compression intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years or older
- Diagnosed with metastatic gastrointestinal cancer, including gastric, pancreatic, colon, or rectal cancer
- Scheduled to receive six cycles of oxaliplatin-based chemotherapy with FOLFOX or FOLFIRINOX
- Having received one cycle of oxaliplatin-based chemotherapy
- Having Grade 2 or higher chemotherapy-induced peripheral neuropathy according to NCI-CTCAE v5.0 before the Cycle 2 intervention
Key exclusion criteria (6 listed)
- Having a diagnosed psychiatric disorder that could interfere with informed consent, communication, or adherence to the study procedures
- Having a cardiac pacemaker or another implanted electronic device contraindicating TENS
- Having pre-existing peripheral neuropathy before the initiation of oxaliplatin-based chemotherapy or neuropathy attributable to another cause
- Having diabetes mellitus
- Having peripheral vascular disease or another clinically significant circulatory disorder affecting the hands or feet
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 |
|---|---|---|
| TENSTENS was delivered using the F. Bosch FB2405 TENS+EMS dual-channel device with four 5 × 5-cm surface electrodes placed bilaterally over PC6 and KI1. Program 4 provided a modulated pulse rate of 2-60 Hz and a pulse width of 156-260 microseconds. The device output was adjustable from 0-80 mA per channel into a 500-Ω load, but no fixed mA value was used. Intensity was individually titrated to a strong, comfortable, non-painful sensory level without visible muscle contraction. Each session lasted 180 minutes: 30 minutes before, throughout the 120-minute oxaliplatin infusion, and 30 minutes after the infusion. Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions. | Device | TENS Group |
| Compression GarmentsBilateral compression of the hands and feet was applied using Beybi Sensitive surgical gloves one size smaller than the participant's measured glove size and knee-high Varimed CCL II graduated compression stockings providing 23-32 mmHg. Each session lasted 180 minutes: 30 minutes before, throughout the 120-minute oxaliplatin infusion, and 30 minutes after the infusion. Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions. All applications were individually fitted and directly supervised by the same research nurse. | Device | Compression group |
| Sequential TENS Plus CompressionParticipants received 90 minutes of TENS followed immediately by 90 minutes of bilateral hand-and-foot compression, using the same devices, parameters, electrode placement, gloves, and stockings as in the monotherapy groups. TENS began 30 minutes before the oxaliplatin infusion and continued during the first 60 minutes of the 120-minute infusion. After TENS was stopped and the electrodes were removed, compression was applied during the remaining 60 minutes of the infusion and for 30 minutes afterward. The total sequential intervention lasted 180 minutes. Sessions were administered every 14 days from Cycle 2 through Cycle 6, for five sessions. | Device | Sequential TENS Plus Compression Group |
Primary outcome
Baseline-Adjusted EORTC QLQ-CIPN20 Total Score Trajectory Across T1-T4
Time frame: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
The EORTC QLQ-CIPN20 is a 20-item patient-reported questionnaire assessing sensory, motor, and autonomic symptoms associated with chemotherapy-induced peripheral neuropathy. Scores are linearly transformed to a 0-100 scale, with higher scores indicating greater CIPN-related symptom burden. The primary outcome was the baseline-adjusted post-baseline trajectory of the EORTC QLQ-CIPN20 total score across T1-T4. The assessments before Cycles 3-6 (T1-T4) were modelled jointly, with the score obtained before Cycle 2 (T0) included as the baseline covariate. The overall Group-by-Time interaction constituted the primary treatment-effect test. Baseline-adjusted between-group contrasts at T4 constituted the primary endpoint pairwise comparisons.
3 secondary outcomes
Baseline-Adjusted EORTC QLQ-C30 Scale Score Trajectories Across T1-T4
Time frame: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
NCI-CTCAE v5.0 Peripheral Sensory Neuropathy Grade Across T1-T4
Time frame: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
DN4 Total Score Trajectory and DN4-Defined Neuropathic Pain Positivity Across T1-T4
Time frame: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Şerife KARAGÖZOĞLU, Proff. study director
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS, Compression Garments and Sequential TENS Plus Compression in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Gastrointestinal Cancers, 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 6 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 9 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?
Baseline-Adjusted EORTC QLQ-CIPN20 Total Score Trajectory Across T1-T4 (time frame: Before Cycles 3, 4, 5, and 6 (T1-T4), corresponding to 2, 4, 6, and 8 weeks after the T0 assessment before Cycle 2; each chemotherapy cycle lasted 14 days.). 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 9 Sep 2026.