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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Control Group | Other | Patients will receive standard clinical care only, with no additional intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks after the first assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deniz Özdemir, Phd | Contact | +905066087130 | dnzzzzdmr@gmail.com | |
| Selda Arslan, Associate Professor | Contact | +905439253200 | seldayarali@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necmettin Erbakan University, Faculty of Health Sciences | Konya | Meram | 42060 | Turkey (Türkiye) |
Individual participant data (IPD) from this study will not be shared due to patient privacy concerns and institutional regulations.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Prospective randomized controlled clinical trial
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In addition to participants and study staff, outcome assessors and data analysts will be blinded to group assignments to minimize bias in evaluating peripheral neuropathy and quality of life outcomes.
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| D017437 |
| Skin and Connective Tissue Diseases |