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

NCT07131618 | Not Yet Recruiting

• 1 other identifier: 2025/302
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gynecological Cancers; Peripheral Neuropathy Due to Chemotherapy

Keywords

Gynecological cancer; cryocompression; peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

intervention

EXPERIMENTAL

Other: cryocompression

control

NO INTERVENTION

Interventions

cryocompression OTHER

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.

intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Related Publications (4)

• Molnar M, Rigo J Jr, Hertelendy F. Signal transduction in human myometrial cells. Acta Physiol Hung. 1996;84(2):89-97.

  PMID: 9046355 BACKGROUND

• 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 BACKGROUND

• Paprocka M, Budzynski W, Kusnierczyk H, Radzikowski C. Effect of cyclophosphamide on mouse bone marrow and leukemic stem cells. Arch Immunol Ther Exp (Warsz). 1980;28(3):447-51.

  PMID: 7447649 BACKGROUND

• Hoki T. [The significance of limbal reaction for corneal antigen-antibody reaction]. Nihon Ganka Kiyo. 1966 Jul;17(7):721-31. No abstract available. Japanese.

  PMID: 6007752 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

burcu okayer özer, MSc, PhD(c)

CONTACT

+905530520077; okayerb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PhD(c), Registered Nurse

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 20, 2025
• Study Start: August 10, 2025
• Primary Completion: November 28, 2025
• Study Completion: December 31, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The IPD will be available within 6 months after publication of the primary results and will remain accessible for up to 5 years.
• Access Criteria: Access will be granted to qualified researchers affiliated with academic or clinical institutions upon submission of a research proposal, signing of a data use agreement, and approval by the principal investigator and relevant ethics committee.