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

Mersin University

Status

Not yet enrolling

Conditions

Peripheral Neuropathy Due to Chemotherapy

Gynecological Cancers

Treatments

Other: cryocompression

Study type

Interventional

Funder types

Other

Identifiers

NCT07131618

2025/302

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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