Necmettin Erbakan University, Faculty of Health Sciences
Konya, Meram, 42060, Turkey (Türkiye)
NCT Number: NCT07504770
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.
Trial opening soon.
Get Notified18 year–80 year
Female
Interventional
Not applicable
Konya, Meram, 42060, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Contact information is provided by the study sponsor or research team.
Deniz Özdemir, Phd
CONTACT
Selda Arslan, Associate Professor
CONTACT
Necmettin Erbakan University
Other
Comparison of Surgical Glove Compressions as a Prophylactic Method to Prevent Paclitaxel-induced Peripheral Neuropathy: Randomized Controlled Trial
Acronym: Surgical Glove
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