Gynecological CancersCryoPNNCT07131618
The Effect of Cryocompression on Peripheral Neuropathy in Patients Receiving Chemotherapy for Gynecological Cancer
A study testing cryocompression in people with Gynecological Cancers and Peripheral Neuropathy Due to Chemotherapy, run by Mersin University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Cancers, Peripheral Neuropathy Due to Chemotherapy
- What is being tested?
- cryocompression
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- cryocompression
- Keywords
- Gynecological cancer, cryocompression, peripheral neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryocompressionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Not described Receives: Other: cryocompression |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week after each chemotherapy cycle (6 weeks total).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start10 Aug 2025 (estimated)
- Primary completion28 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gynecological CancersStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, burcu okayer özer, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131618
- Sponsor's protocol ID
- 2025/302
- Acronym
- CryoPN
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD Sharing Description: Individual participant data (IPD) will not be shared publicly. However, de-identified data may be shared with qualified researchers upon reasonable request, provided that appropriate ethical approvals are obtained. IPD Sharing Time Frame: Upon request, after the publication of the main results. IPD Sharing Access Criteria: Requests will be evaluated on a case-by-case basis and will be subject to institutional and ethics committee approval. IPD Sharing Supporting Information: The study protocol and statistical analysis plan may also be shared.
Publications
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.
PubMed 35147758Scotte 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.
PubMed 15994152Shigematsu 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.
PubMed 32036471Hanai 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.
PubMed 29924336
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cryocompression on Peripheral Neuropathy in Patients Receiving Chemotherapy for Gynecological Cancer
- ClinicalTrials.gov ID
- NCT07131618
- Acronym / sponsor ID
- CryoPN / 2025/302
- Keywords
- Gynecological cancer, cryocompression, peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 28 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: cryocompression |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryocompressionCryocompression 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. | Other | intervention |
Primary outcome
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Results publication: PubMed 35147758Chitkumarn 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.
- Results publication: PubMed 15994152Scotte 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.
- Results publication: PubMed 32036471Shigematsu 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.
- Results publication: PubMed 29924336Hanai 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.
- Individual participant dataSharing planned: Yes. IPD Sharing Description: Individual participant data (IPD) will not be shared publicly. However, de-identified data may be shared with qualified researchers upon reasonable request, provided that appropriate ethical approvals are obtained. IPD Sharing Time Frame: Upon request, after the publication of the main results. IPD Sharing Access Criteria: Requests will be evaluated on a case-by-case basis and will be subject to institutional and ethics committee approval. IPD Sharing Supporting Information: The study protocol and statistical analysis plan may also be shared.
Related trials for Gynecological Cancers
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
RecruitingPhase 1/2
A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)
Tumours, Gynecological
Active, not recruitingObservational study
Diet, Hepcidin, and Chemotherapy RDI
Breast Cancer Female, Ovarian Cancer
RecruitingObservational study
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
Gynaecological Cancers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing cryocompression in people with Gynecological Cancers and Peripheral Neuropathy Due to Chemotherapy, run by Mersin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact burcu okayer özer, MSc, PhD(c) (+905530520077, okayerb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (time frame: One week after each chemotherapy cycle (6 weeks total).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07131618, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.