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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое cryocompression
  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 sock

Первичные конечные точки

• Chemotherapy-Induced Peripheral Neuropathy Assessment Tool [Срок оценки: One week after each chemotherapy cycle (6 weeks total).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Chitkumarn P, Rahong T, Achariyapota V. Efficacy of Siriraj, in-house-developed, frozen gloves for cold therapy reduction of chemotherapy-induced peripheral neuropathy in gynecological cancer patients: randomized controlled trial. Support Care Cancer. 2022 Jun;30(6):4835-4843. doi: 10.1007/s00520-022-06890-1. Epub 2022 Feb 11. PMID 35147758
• Scotte F, Tourani JM, Banu E, Peyromaure M, Levy E, Marsan S, Magherini E, Fabre-Guillevin E, Andrieu JM, Oudard S. Multicenter study of a frozen glove to prevent docetaxel-induced onycholysis and cutaneous toxicity of the hand. J Clin Oncol. 2005 Jul 1;23(19):4424-9. doi: 10.1200/JCO.2005.15.651. PMID 15994152
• Shigematsu H, Hirata T, Nishina M, Yasui D, Ozaki S. Cryotherapy for the prevention of weekly paclitaxel-induced peripheral adverse events in breast cancer patients. Support Care Cancer. 2020 Oct;28(10):5005-5011. doi: 10.1007/s00520-020-05345-9. Epub 2020 Feb 8. PMID 32036471
• Hanai A, Ishiguro H, Sozu T, Tsuda M, Yano I, Nakagawa T, Imai S, Hamabe Y, Toi M, Arai H, Tsuboyama T. Effects of Cryotherapy on Objective and Subjective Symptoms of Paclitaxel-Induced Neuropathy: Prospective Self-Controlled Trial. J Natl Cancer Inst. 2018 Feb 1;110(2):141-148. doi: 10.1093/jnci/djx178. PMID 29924336

Идентификаторы

NCT: NCT07131618 · 2025/302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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