Chemotherapy-induced Peripheral Neuropathy (CIPN)NEURO-GLOVENCT07105553
Glove Compression for Chemotherapy-Induced Neuropathy
A study testing Surgical Glove Compression in people with Chemotherapy-induced Peripheral Neuropathy (CIPN) and Gynecologic Cancers, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study investigates whether wearing tight-fitting surgical gloves on the non-dominant hand could help prevent chemotherapy-induced peripheral neuropathy (CIPN) in women with gynecologic cancers treated with paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy (CIPN), Gynecologic Cancers, Ovarian Cancer (OvCa)
- What is being tested?
- Surgical Glove Compression
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 11 Jul 2025
- 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 patients aged ≥18 years
- Histologically confirmed gynecologic malignancy (e.g., ovarian, or endometrial cancer)
- Scheduled to receive carboplatin-paclitaxel chemotherapy administered every 21 days
- Planned for a total of six chemotherapy cycles
- ECOG performance status 0-2
- Ability to provide written informed consent
Who cannot join
- Patients receiving neoadjuvant chemotherapy with planned surgery
- Patients receiving weekly (dose-dense) paclitaxel regimens
- Prior exposure to neurotoxic chemotherapy agents (e.g., taxanes, platinum compounds, proteasome inhibitors, anti-tubulin agents)
- History of pre-existing peripheral neuropathy
- Known allergy to latex or surgical gloves
- Diagnosed peripheral vascular disease
Show all 11Show fewer
- Concurrent use of medications that may mask or modulate neuropathy symptoms (e.g., gabapentinoids, SNRIs, vitamin B complex, alpha-lipoic acid)
- Clinical diagnosis of diabetic neuropathy or history of alcohol-related neuropathy
- Raynaud's phenomenon or other cold-sensitive vascular conditions
- Other neurological disorders that may interfere with neuropathy assessment
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik City Hospital
Ankara, Yenimahalle, 06170
About this study
Official title: Neuro Glove: A Prospective Self-Controlled Study of Glove Compression as a Protective Strategy Against Chemotherapy-Induced Peripheral Neuropathy in Women With Gynecologic Malignancies
This study investigates whether wearing tight-fitting surgical gloves on the non-dominant hand could help prevent chemotherapy-induced peripheral neuropathy (CIPN) in women with gynecologic cancers treated with paclitaxel. In this prospective, self-controlled observational study, seventy-six patients wear two tight surgical gloves on their non-dominant hand during each paclitaxel infusion. The dominant hand, without gloves, serves as a control. Neuropathy symptoms are assessed using the EORTC QLQ-CIPN20 questionnaire at baseline, mid-treatment, and end of treatment. Electromyography (EMG) is performed if clinically indicated.
Read the detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, dose-limiting, and often persistent adverse effect of taxane-based chemotherapy, particularly in women with gynecologic malignancies. CIPN significantly impairs quality of life and may necessitate chemotherapy dose reductions or discontinuation. Despite its clinical relevance, no pharmacologic agent has been proven to prevent CIPN. Accordingly, non-pharmacologic strategies such as physical compression have gained attention as potential neuroprotective interventions.
This prospective, non-randomized, self-controlled observational study is being conducted at Etlik City Hospital, Ankara, Türkiye. A total of seventy-six female patients aged 18 years or older with histologically confirmed gynecologic cancers (endometrial and ovarian) scheduled to receive six cycles of carboplatin-paclitaxel chemotherapy was enrolled. The intervention involves applying two tight-fitting surgical gloves (one size smaller than standard) to the non-dominant hand starting 30 minutes before each paclitaxel infusion, worn throughout the infusion, and removed 30 minutes afterward. The dominant hand, without compression, serves as an internal control.
Peripheral neuropathy symptoms are assessed using the EORTC QLQ-CIPN20 questionnaire, a validated tool developed by the European Organisation for Research and Treatment of Cancer. The Turkish version has been previously validated. The CIPN20 includes twenty items scored on a 1 (not at all) to 4 (very much) Likert scale, yielding a total score range from 20 to 80. CIPN20 assessments are conducted at baseline (prior to treatment), after cycle three, and after cycle six. Neurological consultation and electromyography (EMG) are performed only in patients reporting significant neuropathic symptoms and if clinically indicated.
All data collection occurs during routine clinical visits. The study remains entirely non-interventional and is integrated into standard oncology care without additional diagnostic or procedural burdens to participants. The primary objective is to evaluate the feasibility and potential role of glove compression in mitigating CIPN development in the intervention hand compared to the control hand, using validated patient-reported outcome measures.
- Conditions
- Chemotherapy-induced Peripheral Neuropathy (CIPN), Gynecologic Cancers, Ovarian Cancer (OvCa), Endometrial Cancer
- Being tested
- Surgical Glove Compression
- Keywords
- Peripheral Neuropathy, CIPN, Taxane Toxicity, Surgical Glove Compression, Supportive Care in Oncology, EORTC QLQ-CIPN20, Gynecologic Malignancy
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Glove CompressionDevice
Also called Physical Compression Using Tight-Fitting Gloves
Participants wore two tight-fitting surgical gloves (one size smaller than standard) on the non-dominant hand. The gloves were applied 30 minutes prior to each paclitaxel infusion, remained in place during the infusion, and were removed 30 minutes afterward. The dominant hand remained ungloved and served as an internal control. This intervention was entirely non-pharmacologic and was integrated into routine chemotherapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Single Cohort - Self-Controlled | Experimental | This arm includes female patients with gynecologic malignancies receiving paclitaxel-based chemotherapy. Each participant's non-dominant hand received the intervention of two tight-fitting surgical gloves (one size smaller than standard), while the dominant hand remained ungloved and served as an internal control. The gloves were worn during each paclitaxel infusion, starting 30 minutes before the infusion and removed 30 minutes after completion. Neuropathy was assessed using the EORTC QLQ-CIPN20 questionnaire at baseline, after cycle 3, and at the end of treatment. No additional clinical visits were scheduled outside of routine oncology care. Receives: Device: Surgical Glove Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy (CIPN) in the Intervention vs. Control Hand
Peripheral neuropathy severity will be assessed using the validated EORTC QLQ-CIPN20 questionnaire. The sensory subscale score ranges from 0 to 100, with higher scores indicating worse symptoms. A total score of ≥25 will be defined as grade 2 or higher neuropathy. Each patient will serve as their own control: the non-dominant hand will receive the surgical glove compression intervention, while the dominant hand will not. The difference in incidence of grade ≥2 neuropathy between the two hands will be evaluated.
Unit of Measure: Percentage of patients with grade ≥2 neuropathy, defined as a sensory score ≥25 on the EORTC QLQ-CIPN20 (range 0-100; higher scores indicate worse symptoms).
Measured: At Day 1 (baseline, prior to chemotherapy), Day 64 (after Cycle 3), and Day 127 (after Cycle 6); each chemotherapy cycle is 21 days.
Secondary outcomes (4)
Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy by Baseline Weight Loss Status
Peripheral neuropathy severity will be assessed using the validated EORTC QLQ-CIPN20 questionnaire. Scores range from 0 to 100, with higher scores indicating worse symptoms. A total sensory score ≥25 will be defined as grade 2 or higher neuropathy. This outcome evaluates whether baseline weight loss of ≥10% is associated with the development of grade ≥2 CIPN at the end of treatment. Analyses will include multivariate regression models.
Unit of Measure: Percentage of patients with grade ≥2 CIPN (EORTC QLQ-CIPN20 score ≥25)
Measured: From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 days.
Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy by ECOG Performance Status
Peripheral neuropathy severity will be assessed using the validated EORTC QLQ-CIPN20 questionnaire. Scores range from 0 to 100, with higher scores indicating worse symptoms. A total sensory score ≥25 will be defined as grade 2 or higher neuropathy. This outcome evaluates whether ECOG performance status is associated with the development of grade ≥2 CIPN at the end of treatment. Analyses will include multivariate regression models.
Unit of Measure: Percentage of patients with grade ≥2 CIPN (EORTC QLQ-CIPN20 score ≥25)
Measured: From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 days.
Change in EORTC QLQ-CIPN20 Sensory Score Over Time
Peripheral neuropathy will be assessed using the validated EORTC QLQ-CIPN20 sensory subscale, which ranges from 0 to 100, with higher scores indicating worse symptoms. This outcome measures the change in sensory score from baseline to mid-treatment (Week 9) and post-treatment (Week 18), comparing the intervention (gloved) and control (non-gloved) hands.
Unit of Measure: Mean change in sensory score (range 0-one hundred)
Measured: At Day 1 (baseline, prior to chemotherapy), Day 64 (after Cycle 3), and Day 127 (after Cycle 6); each chemotherapy cycle is 21 days.
Change in Quality of Life Based on EORTC QLQ-C30 Global Health Status
Quality of life will be assessed using the Global Health Status subscale of the validated EORTC QLQ-C30 questionnaire. Scores range from 0 to 100, with higher scores indicating better quality of life. This outcome measures the change in Global Health Status scores from baseline to the end of treatment.
Unit of Measure: Mean change in Global Health Status score (range 0-100)
Measured: From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral Neuropathy (CIPN)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same intervention, consisting of tight-fitting surgical gloves worn on the non-dominant hand during paclitaxel infusion. The dominant hand serves as an internal control for each participant. This single-group, self-controlled design allows intra-individual comparison of neuropathy outcomes.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Galip Can Uyar, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105553
- Sponsor's protocol ID
- AEŞH-EK1-2023-828
- Other IDs
- AEŞH-EK1-2023-828
- Acronym
- NEURO-GLOVE
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baskurt K, Uyar GC, Yesilbas E, Altunc FZ, Cevik DE, Melek IM, Eren Y, Oksuzoglu OBC, Yucel KB, Di Meglio A, Ray-Coquard I, Sutcuoglu O. Limb Compression Therapy and Chemotherapy-Induced Peripheral Neuropathy in Women With Gynecologic Cancers: A Prospective Self-Controlled Study(NEURO-GLOVE Trial). Int J Cancer. 2026 Jun 18. doi: 10.1002/ijc.70601. Online ahead of print.
PubMed 42311202
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro Glove: A Prospective Self-Controlled Study of Glove Compression as a Protective Strategy Against Chemotherapy-Induced Peripheral Neuropathy in Women With Gynecologic Malignancies
- ClinicalTrials.gov ID
- NCT07105553
- Acronym / sponsor ID
- NEURO-GLOVE / AEŞH-EK1-2023-828
- Conditions
- Chemotherapy-induced Peripheral Neuropathy (CIPN), Gynecologic Cancers, Ovarian Cancer (OvCa), Endometrial Cancer
- Keywords
- Peripheral Neuropathy, CIPN, Taxane Toxicity, Surgical Glove Compression, Supportive Care in Oncology, EORTC QLQ-CIPN20, Gynecologic Malignancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 6 Aug 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 study investigates whether wearing tight-fitting surgical gloves on the non-dominant hand could help prevent chemotherapy-induced peripheral neuropathy (CIPN) in women with gynecologic cancers treated with paclitaxel. In this prospective, self-controlled observational study, seventy-six patients wear two tight surgical gloves on their non-dominant hand during each paclitaxel infusion. The dominant hand, without gloves, serves as a control. Neuropathy symptoms are assessed using the EORTC QLQ-CIPN20 questionnaire at baseline, mid-treatment, and end of treatment. Electromyography (EMG) is performed if clinically indicated.
Detailed description
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, dose-limiting, and often persistent adverse effect of taxane-based chemotherapy, particularly in women with gynecologic malignancies. CIPN significantly impairs quality of life and may necessitate chemotherapy dose reductions or discontinuation. Despite its clinical relevance, no pharmacologic agent has been proven to prevent CIPN. Accordingly, non-pharmacologic strategies such as physical compression have gained attention as potential neuroprotective interventions.
This prospective, non-randomized, self-controlled observational study is being conducted at Etlik City Hospital, Ankara, Türkiye. A total of seventy-six female patients aged 18 years or older with histologically confirmed gynecologic cancers (endometrial and ovarian) scheduled to receive six cycles of carboplatin-paclitaxel chemotherapy was enrolled. The intervention involves applying two tight-fitting surgical gloves (one size smaller than standard) to the non-dominant hand starting 30 minutes before each paclitaxel infusion, worn throughout the infusion, and removed 30 minutes afterward. The dominant hand, without compression, serves as an internal control.
Peripheral neuropathy symptoms are assessed using the EORTC QLQ-CIPN20 questionnaire, a validated tool developed by the European Organisation for Research and Treatment of Cancer. The Turkish version has been previously validated. The CIPN20 includes twenty items scored on a 1 (not at all) to 4 (very much) Likert scale, yielding a total score range from 20 to 80. CIPN20 assessments are conducted at baseline (prior to treatment), after cycle three, and after cycle six. Neurological consultation and electromyography (EMG) are performed only in patients reporting significant neuropathic symptoms and if clinically indicated.
All data collection occurs during routine clinical visits. The study remains entirely non-interventional and is integrated into standard oncology care without additional diagnostic or procedural burdens to participants. The primary objective is to evaluate the feasibility and potential role of glove compression in mitigating CIPN development in the intervention hand compared to the control hand, using validated patient-reported outcome measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same intervention, consisting of tight-fitting surgical gloves worn on the non-dominant hand during paclitaxel infusion. The dominant hand serves as an internal control for each participant. This single-group, self-controlled design allows intra-individual comparison of neuropathy outcomes.
| Arm | Type | Receives |
|---|---|---|
| Single Cohort - Self-Controlled | Experimental | Device: Surgical Glove CompressionThis arm includes female patients with gynecologic malignancies receiving paclitaxel-based chemotherapy. Each participant's non-dominant hand received the intervention of two tight-fitting surgical gloves (one size smaller than standard), while the dominant hand remained ungloved and served as an internal control. The gloves were worn during each paclitaxel infusion, starting 30 minutes before the infusion and removed 30 minutes after completion. Neuropathy was assessed using the EORTC QLQ-CIPN20 questionnaire at baseline, after cycle 3, and at the end of treatment. No additional clinical visits were scheduled outside of routine oncology care. |
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)
- Female patients aged ≥18 years
- Histologically confirmed gynecologic malignancy (e.g., ovarian, or endometrial cancer)
- Scheduled to receive carboplatin-paclitaxel chemotherapy administered every 21 days
- Planned for a total of six chemotherapy cycles
- ECOG performance status 0-2
Key exclusion criteria (11 listed)
- Patients receiving neoadjuvant chemotherapy with planned surgery
- Patients receiving weekly (dose-dense) paclitaxel regimens
- Prior exposure to neurotoxic chemotherapy agents (e.g., taxanes, platinum compounds, proteasome inhibitors, anti-tubulin agents)
- History of pre-existing peripheral neuropathy
- Known allergy to latex or surgical gloves
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 |
|---|---|---|
| Surgical Glove CompressionAlso: Physical Compression Using Tight-Fitting GlovesParticipants wore two tight-fitting surgical gloves (one size smaller than standard) on the non-dominant hand. The gloves were applied 30 minutes prior to each paclitaxel infusion, remained in place during the infusion, and were removed 30 minutes afterward. The dominant hand remained ungloved and served as an internal control. This intervention was entirely non-pharmacologic and was integrated into routine chemotherapy sessions. | Device | Single Cohort - Self-Controlled |
Primary outcome
Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy (CIPN) in the Intervention vs. Control Hand
Time frame: At Day 1 (baseline, prior to chemotherapy), Day 64 (after Cycle 3), and Day 127 (after Cycle 6); each chemotherapy cycle is 21 days.
Peripheral neuropathy severity will be assessed using the validated EORTC QLQ-CIPN20 questionnaire. The sensory subscale score ranges from 0 to 100, with higher scores indicating worse symptoms. A total score of ≥25 will be defined as grade 2 or higher neuropathy. Each patient will serve as their own control: the non-dominant hand will receive the surgical glove compression intervention, while the dominant hand will not. The difference in incidence of grade ≥2 neuropathy between the two hands will be evaluated. Unit of Measure: Percentage of patients with grade ≥2 neuropathy, defined as a sensory score ≥25 on the EORTC QLQ-CIPN20 (range 0-100; higher scores indicate worse symptoms).
4 secondary outcomes
Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy by Baseline Weight Loss Status
Time frame: From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 days.
Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy by ECOG Performance Status
Time frame: From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 days.
Change in EORTC QLQ-CIPN20 Sensory Score Over Time
Time frame: At Day 1 (baseline, prior to chemotherapy), Day 64 (after Cycle 3), and Day 127 (after Cycle 6); each chemotherapy cycle is 21 days.
Change in Quality of Life Based on EORTC QLQ-C30 Global Health Status
Time frame: From baseline (Day 1) to end of treatment (Day 127, after Cycle 6); each cycle is 21 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 6 Aug 2025.
- Derived from this study: PubMed 42311202Baskurt K, Uyar GC, Yesilbas E, Altunc FZ, Cevik DE, Melek IM, Eren Y, Oksuzoglu OBC, Yucel KB, Di Meglio A, Ray-Coquard I, Sutcuoglu O. Limb Compression Therapy and Chemotherapy-Induced Peripheral Neuropathy in Women With Gynecologic Cancers: A Prospective Self-Controlled Study(NEURO-GLOVE Trial). Int J Cancer. 2026 Jun 18. doi: 10.1002/ijc.70601. Online ahead of print.
- 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.
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 Surgical Glove Compression in people with Chemotherapy-induced Peripheral Neuropathy (CIPN) and Gynecologic Cancers, run by Ankara Etlik City Hospital 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 11 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 6 Aug 2025. 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?
Incidence of Grade ≥2 Chemotherapy-Induced Peripheral Neuropathy (CIPN) in the Intervention vs. Control Hand (time frame: At Day 1 (baseline, prior to chemotherapy), Day 64 (after Cycle 3), and Day 127 (after Cycle 6); each chemotherapy cycle is 21 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07105553, which also lists 1 linked publication.
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 6 Aug 2025.