Surgical Glove Compression to Prevent Paclitaxel Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surgical glove compression during paclitaxel infusion.
- Who it may be relevant to
- Registry conditions: Paclitaxel-Induced Peripheral Neuropathy, Breast Cancer, Surgical Glove. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Surgical Glove Compressions as a Prophylactic Method to Prevent Paclitaxel-induced Peripheral Neuropathy: Randomized Controlled Trial
Overview
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.
Interventions
- Other Surgical glove compression during paclitaxel infusion
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
Primary outcome measures
- Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) [Time frame: 4 weeks after the first assessment]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Necmettin Erbakan University, Faculty of Health Sciences — Konya
Identifiers
NCT: NCT07504770 · 24272