The Effect of Cryocompression on Peripheral Neuropathy in Patients Receiving Chemotherapy for Gynecological Cancer

ConditionsGynecological Cancers Peripheral Neuropathy Due to Chemotherapy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorMersin University

About this trial

Study Design:

This study is designed as a prospective, randomized controlled experimental study aiming to determine the effect of cryocompression therapy, applied during chemotherapy, on peripheral neuropathy symptoms in women with gynecologic cancers.

Research Hypotheses:

* H₀: Cryocompression therapy has no effect on peripheral neuropathy. * H₁: Cryocompression therapy has an effect on peripheral neuropathy.

Study Population:

The study population will consist of women over the age of 18 living in Mersin, Türkiye, who are diagnosed with gynecologic cancer and undergoing chemotherapy between August 10 and December 31, 2025.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Applying to Mersin University Hospital Oncology Outpatient Clinic

Willing to participate and providing signed informed consent

Able to read and write in Turkish

Accessible and able to communicate

Disqualifiers

Not applying to the specified outpatient clinic

No gynecologic cancer diagnosis or younger than 18 years old

Not providing informed consent

Not receiving weekly carboplatin + paclitaxel chemotherapy protocol

Trial design

Design model

Parallel

Treatments tested in this trial

cryocompression
Other intervention
Cryocompression induces vasoconstriction in the applied area, thereby reducing blood flow. As a result, the delivery of the chemotherapeutic agent to peripheral nerves is limited, and it is aimed to protect nerve tissue from toxic effects. At the same time, low temperature slows down nerve conduction and cellular metabolism, helping to prevent damage to nerve cells. 30 minutes after the start of the paclitaxel infusion, cryocompression will be applied using ice gel gloves for the hands and socks for the feet, lasting 30 minutes. After paclitaxel ends, carboplatin will be infused intravenously in 250 cc isotonic solution over 1 hour. Cryocompression will again be applied 30 minutes after the start of the carboplatin infusion using the same method, for 30 minutes. This intervention will be performed weekly during each cycle of the 6-week carboplatin/paclitaxel protocol, for a total of 60 minutes per session.

Treatment groups

78 Participants

are divided into 2 treatment groups

Group A: interventionExperimental treatment 1 intervention

Group B: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Chemotherapy-Induced Peripheral Neuropathy Assessment Tool

Change in peripheral neuropathy severity measured by the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) Scale range: 0 to 80 (higher scores indicate more severe neuropathy symptoms). Time Frame: One week after each weekly chemotherapy cycle, for six cycles (total 6 weeks). Description: Peripheral neuropathy severity will be assessed using the CIPNAT scale, which evaluates sensory, motor, and autonomic symptoms associated with chemotherapy-induced peripheral neuropathy. Scores from all six cycles will be summed for analysis.

Time frame

One week after each chemotherapy cycle (6 weeks total).

Locations

This trial has no locations.

Sponsors and contacts

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

Mersin University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: