Surgical Glove Compression to Prevent Paclitaxel Neuropathy

ConditionsPaclitaxel-Induced Peripheral Neuropathy Breast Cancer Surgical Glove

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-80

SponsorNecmettin Erbakan University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Recurrent breast cancer

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

Trial design

Design model

Parallel

Treatments tested in this trial

Surgical glove compression during paclitaxel infusion
Other intervention
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.

Treatment groups

84 Participants

are divided into 3 treatment groups

Group A: Intervention Group 1Other 1 intervention

Group B: Intervention Group 2Other 1 intervention

Group C: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

4 weeks after the first assessment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Necmettin Erbakan University

Lead sponsor

Konya City Hospital

Sponsor institution

Source ClinicalTrials.gov

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