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NCT Number: NCT07504770

Surgical Glove Compression to Prevent Paclitaxel Neuropathy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University, Faculty of Health Sciences

Konya, Meram, 42060, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%)

Exclusion criteria

  • Recurrent breast cancer
  • Prior treatment associated with neuropathy (e.g., taxanes, platinum-based chemotherapy, anti-tubulin or proteasome inhibitors)

Treatment and study plan

Surgical glove compression during paclitaxel infusion

Other

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Deniz Özdemir, Phd

CONTACT

[email protected]

+905066087130

Selda Arslan, Associate Professor

CONTACT

[email protected]

+905439253200

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

Comparison of Surgical Glove Compressions as a Prophylactic Method to Prevent Paclitaxel-induced Peripheral Neuropathy: Randomized Controlled Trial

Acronym: Surgical Glove

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 1, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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