Paclitaxel-Induced Peripheral NeuropathySurgical GloveNCT07504770
Surgical Glove Compression to Prevent Paclitaxel Neuropathy
A study testing Surgical glove compression during paclitaxel infusion in people with Paclitaxel-Induced Peripheral Neuropathy and Breast Cancer, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of surgical glove compression as a prophylactic method to prevent paclitaxel-induced peripheral neuropathy. Participants will be randomly assigned to two groups: one receiving standard care, and the other receiving prophylactic surgical glove compression. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Paclitaxel-Induced Peripheral Neuropathy, Breast Cancer, Surgical Glove
- What is being tested?
- Surgical glove compression during paclitaxel infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Mar 2026to 26 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 80 years
- Diagnosed with Stage II-III breast cancer
- No distant metastasis
- Planned to receive adjuvant or neoadjuvant paclitaxel for at least 12 weeks
- Willing and able to provide informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Karnofsky ≥ 60%)
Who cannot join
- Recurrent breast cancer
- Prior treatment associated with neuropathy (e.g., taxanes, platinum-based chemotherapy, anti-tubulin or proteasome inhibitors)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Faculty of Health Sciences
Konya, Meram, 42060
About this study
Official title: Comparison of Surgical Glove Compressions as a Prophylactic Method to Prevent Paclitaxel-induced Peripheral Neuropathy: Randomized Controlled Trial
This study aims to evaluate the effect of surgical glove compression as a prophylactic method to prevent paclitaxel-induced peripheral neuropathy. Participants will be randomly assigned to two groups: one receiving standard care, and the other receiving prophylactic surgical glove compression. The study will compare the development, severity of neuropathy in the hands and fingers, and its impact on quality of life.
Read the detailed description
This study aims to evaluate the effectiveness of surgical glove compression to prevent peripheral neuropathy in patients receiving paclitaxel. Participants will be divided into two groups: one receiving standard care, and the other receiving glove compression. The study will compare the development and severity of neuropathy in the hands and fingers, as well as its impact on quality of life. This method is considered a practical, cost-effective, and well-tolerated preventive approach.
Method:
Patients receiving paclitaxel will be randomly assigned to either the intervention or control group.
Intervention Group 1: Each patient will wear a standard surgical glove (½ size smaller) on the same hand for all treatment sessions. Since surgeons typically use gloves that fit their hands perfectly, a standard-sized surgical glove is defined as a "surgeon fit." Gloves will be worn 30 minutes before paclitaxel infusion, during the infusion, and 30 minutes after the infusion. This procedure will be repeated at every treatment session. No additional interventions will be applied. Gloves must fit the patient's hands properly. The study nurse will determine the appropriate glove size for each patient by measuring from the base of the palm to the tip of the middle finger. The measurements will be converted to glove sizes using a reference table.
Intervention Group 2: Each patient will wear two standard surgical gloves on the same hand: the first ½ size smaller and the second one size smaller. Gloves will be worn 30 minutes before paclitaxel infusion, during the infusion, and 30 minutes after. This procedure will be repeated at every treatment session. No additional interventions will be applied. Gloves must fit the patient's hands properly. The study nurse will determine the appropriate glove size for each patient.
Control Group: Patients in the control group will receive standard clinical care only, without any additional interventions.
Widespread Effect If effective, surgical glove compression could provide a simple, low-cost, and widely accessible method to prevent paclitaxel-induced peripheral neuropathy, improving quality of life for patients undergoing chemotherapy and potentially influencing supportive care practices in oncology settings.
- Being tested
- Surgical glove compression during paclitaxel infusion
- Keywords
- Surgical Glove, Paclitaxel-Induced Peripheral Neuropathy, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical glove compression during paclitaxel infusionOther
n the intervention group, each patient will wear two standard surgical gloves on the same single hand throughout the study (the first glove will be half a size smaller, the second glove one size smaller). The gloves will be worn 30 minutes before the paclitaxel infusion, during the infusion, and for 30 minutes after the infusion. This procedure will be performed each time the patient comes for treatment. No additional interventions will be applied besides the surgical gloves. The gloves must fit the patients' hands properly, and the study nurse will determine the appropriate glove size for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1 | Other | A standard surgical glove (½ size smaller) will be worn on the same hand 30 minutes before, during, and 30 minutes after paclitaxel infusion. Glove size will be determined by the study nurse based on hand measurements. Receives: Other: Surgical glove compression during paclitaxel infusion |
| Intervention Group 2 | Other | Two standard surgical gloves will be worn on the same hand: first ½ size smaller, second 1 size smaller. Gloves will be worn 30 minutes before, during, and 30 minutes after paclitaxel infusion. Glove sizes determined by study nurse. Receives: Other: Surgical glove compression during paclitaxel infusion |
| Control Group | Other | Patients will receive standard clinical care only, with no additional intervention. Receives: Other: Surgical glove compression during paclitaxel infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
The first section assesses the nine main symptoms as well as their severity, the extent to which they cause emotional disruption, and the frequency of their occurrence. The first six items in this section are related to sensory symptoms, while the seventh, eighth and ninth items are related to sub-dimensions of motor symptoms. In the second part, 14 activities were evaluated and questions were asked about the effect level of these substances. The activities assessed included fine motor and general activities. To assess the symptoms listed in the first section, "Yes" was considered equal to 1 point and "No" equal to 0 (0-9); their severity, symptoms, extent and frequency of emotional impairment were scored between 0 and 10 (0-270). The total score for the first part of the instrument is between 0 and 279. The effect level on the 14 activities in the second part was calculated between 0 and 10 (0-140). The Cronbach's alpha value of the original scale is 0.95
Measured: 4 weeks after the first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start26 Mar 2026 (estimated)
- Primary completion26 Oct 2026 (estimated)
- Study completion26 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paclitaxel-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Prospective randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Ozdemir, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504770
- Sponsor's protocol ID
- 24272
- Acronym
- Surgical Glove
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared due to patient privacy concerns and institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Glove Compressions as a Prophylactic Method to Prevent Paclitaxel-induced Peripheral Neuropathy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07504770
- Acronym / sponsor ID
- Surgical Glove / 24272
- Keywords
- Surgical Glove, Paclitaxel-Induced Peripheral Neuropathy, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 26 Mar 2026 (estimated)
- Primary completion
- 26 Oct 2026 (estimated)
- Study completion
- 26 Mar 2027 (estimated)
- First posted
- 1 Apr 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 study aims to evaluate the effect of surgical glove compression as a prophylactic method to prevent paclitaxel-induced peripheral neuropathy. Participants will be randomly assigned to two groups: one receiving standard care, and the other receiving prophylactic surgical glove compression. The study will compare the development, severity of neuropathy in the hands and fingers, and its impact on quality of life.
Detailed description
This study aims to evaluate the effectiveness of surgical glove compression to prevent peripheral neuropathy in patients receiving paclitaxel. Participants will be divided into two groups: one receiving standard care, and the other receiving glove compression. The study will compare the development and severity of neuropathy in the hands and fingers, as well as its impact on quality of life. This method is considered a practical, cost-effective, and well-tolerated preventive approach.
Method:
Patients receiving paclitaxel will be randomly assigned to either the intervention or control group.
Intervention Group 1: Each patient will wear a standard surgical glove (½ size smaller) on the same hand for all treatment sessions. Since surgeons typically use gloves that fit their hands perfectly, a standard-sized surgical glove is defined as a "surgeon fit." Gloves will be worn 30 minutes before paclitaxel infusion, during the infusion, and 30 minutes after the infusion. This procedure will be repeated at every treatment session. No additional interventions will be applied. Gloves must fit the patient's hands properly. The study nurse will determine the appropriate glove size for each patient by measuring from the base of the palm to the tip of the middle finger. The measurements will be converted to glove sizes using a reference table.
Intervention Group 2: Each patient will wear two standard surgical gloves on the same hand: the first ½ size smaller and the second one size smaller. Gloves will be worn 30 minutes before paclitaxel infusion, during the infusion, and 30 minutes after. This procedure will be repeated at every treatment session. No additional interventions will be applied. Gloves must fit the patient's hands properly. The study nurse will determine the appropriate glove size for each patient.
Control Group: Patients in the control group will receive standard clinical care only, without any additional interventions.
Widespread Effect If effective, surgical glove compression could provide a simple, low-cost, and widely accessible method to prevent paclitaxel-induced peripheral neuropathy, improving quality of life for patients undergoing chemotherapy and potentially influencing supportive care practices in oncology settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1 | Other | Other: Surgical glove compression during paclitaxel infusionA standard surgical glove (½ size smaller) will be worn on the same hand 30 minutes before, during, and 30 minutes after paclitaxel infusion. Glove size will be determined by the study nurse based on hand measurements. |
| Intervention Group 2 | Other | Other: Surgical glove compression during paclitaxel infusionTwo standard surgical gloves will be worn on the same hand: first ½ size smaller, second 1 size smaller. Gloves will be worn 30 minutes before, during, and 30 minutes after paclitaxel infusion. Glove sizes determined by study nurse. |
| Control Group | Other | Other: Surgical glove compression during paclitaxel infusionPatients will receive standard clinical care only, with no additional intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged between 18 and 80 years
- Diagnosed with Stage II-III breast cancer
- No distant metastasis
- Planned to receive adjuvant or neoadjuvant paclitaxel for at least 12 weeks
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Recurrent breast cancer
- Prior treatment associated with neuropathy (e.g., taxanes, platinum-based chemotherapy, anti-tubulin or proteasome inhibitors)
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 compression during paclitaxel infusionn the intervention group, each patient will wear two standard surgical gloves on the same single hand throughout the study (the first glove will be half a size smaller, the second glove one size smaller). The gloves will be worn 30 minutes before the paclitaxel infusion, during the infusion, and for 30 minutes after the infusion. This procedure will be performed each time the patient comes for treatment. No additional interventions will be applied besides the surgical gloves. The gloves must fit the patients' hands properly, and the study nurse will determine the appropriate glove size for each patient. | Other | Control Group, Intervention Group 1, Intervention Group 2 |
Primary outcome
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
Time frame: 4 weeks after the first assessment
The first section assesses the nine main symptoms as well as their severity, the extent to which they cause emotional disruption, and the frequency of their occurrence. The first six items in this section are related to sensory symptoms, while the seventh, eighth and ninth items are related to sub-dimensions of motor symptoms. In the second part, 14 activities were evaluated and questions were asked about the effect level of these substances. The activities assessed included fine motor and general activities. To assess the symptoms listed in the first section, "Yes" was considered equal to 1 point and "No" equal to 0 (0-9); their severity, symptoms, extent and frequency of emotional impairment were scored between 0 and 10 (0-270). The total score for the first part of the instrument is between 0 and 279. The effect level on the 14 activities in the second part was calculated between 0 and 10 (0-140). The Cronbach's alpha value of the original scale is 0.95
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared due to patient privacy concerns and institutional regulations.
Related trials for Paclitaxel-Induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruitingPhase 2
Evaluation of the Effect of Amantadine in the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients
Breast Cancer, Peripheral Neuropathy Due to Chemotherapy
Active, not recruitingPhase 2
Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel
Anatomic Stage IV Breast Cancer AJCC v8, Chemotherapy-Induced Peripheral Neuropathy
RecruitingPhase 2
Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel
Chemotherapy-induced Peripheral Neuropathy
Active, not recruitingPhase 2
Docetaxel or Paclitaxel in Reducing Chemotherapy-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical glove compression during paclitaxel infusion in people with Paclitaxel-Induced Peripheral Neuropathy and Breast Cancer, run by Necmettin Erbakan 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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deniz Özdemir, Phd (+905066087130, dnzzzzdmr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) (time frame: 4 weeks after the first assessment). 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 17 Apr 2026.