Gynecological Cancers, Peripheral Neuropathy Due to Chemotherapy
Conditions
Keywords
Gynecological cancer, cryocompression, peripheral neuropathy
Brief summary
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.
Detailed description
This study will be conducted with women diagnosed with gynecological cancer who apply to the Oncology Outpatient Clinic and Ambulatory Chemotherapy Unit of Mersin University Hospital and voluntarily agree to participate in the research. The sample size was calculated using the G\*Power 3.1.9.7 program, based on the Chi-Square Test of Independence. In a previous study, the incidence of peripheral neuropathy was reported as 28.2% in the cold therapy group and 57.5% in the control group. Using these data, with a 5% margin of error (α = 0.05) and 80% power (1-β = 0.80), the required sample size was determined to be 35 participants per group. Considering potential data loss, the sample size in each group was increased by approximately 10%, resulting in 39 participants per group. A total of 78 participants will be included in the study. Inclusion Criteria: Age 18 years or older, Diagnosed with gynecological cancer, Receiving weekly carboplatin-paclitaxel chemotherapy protocol, Willing to participate in the study and signing the informed consent form. Intervention: Participants will be randomly assigned into two groups: Intervention Group: Cryocompression will be applied during chemotherapy using glove- and sock-shaped cryotherapy devices. The application will begin 15 minutes before the start of chemotherapy infusion, continue during chemotherapy administration, and last for an additional 15 minutes after infusion completion. Control Group: Standard chemotherapy treatment will be administered without any additional intervention. Data Collection Process: After obtaining ethics committee approval, eligible women who meet the study criteria and agree to participate will be given verbal and written information about the study. The informed consent form will be included on the first page of the data collection tool. Those who sign the consent form will complete the questionnaire, which is expected to take approximately 10 minutes. Study Timeline: Participant recruitment will begin on August 10, 2025, and will be completed by December 31, 2025.
Interventions
OTHERcryocompression
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.
Sponsors
Mersin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Citizen of the Republic of Türkiye * Diagnosed with gynecologic cancer (ovarian, endometrial, or cervical) and aged ≥18 years * Receiving weekly carboplatin + paclitaxel chemotherapy protocol * No subjective peripheral neuropathy symptoms before starting chemotherapy * No history of peripheral neuropathy related to previous taxane/platinum-based chemotherapy protocols * No psychiatric disorders * No diseases that may cause peripheral neuropathy such as diabetes, rheumatoid arthritis, or fibromyalgia
Exclusion criteria
* 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 * Presence of subjective peripheral neuropathy symptoms before starting chemotherapy * History of peripheral neuropathy related to previous taxane/platinum-based chemotherapy protocols * Presence of psychiatric disorders * Having diseases that may cause peripheral neuropathy such as diabetes, rheumatoid arthritis, or fibromyalgia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy-Induced Peripheral Neuropathy Assessment Tool | One week after each chemotherapy cycle (6 weeks total). | 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. |
Contacts
Primary Contactburcu okayer özer, MSc, PhD(c)
Outcome results
None listed