Peripheral NeuropathyNCT06488963
The Effect of Cold Therapy on Peripheral Neuropathy
A study testing NatraCure Cold Therapy gloves and socks in people with Peripheral Neuropathy, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
This study examines the feasibility, acceptability, and efficacy of cold therapy on vincristine-induced peripheral neuropathy (VIPN) in pediatric patients with cancer. Vincristine (VCR) is one of the most used vinca alkaloid chemotherapy in pediatric oncology patients. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Peripheral Neuropathy
- What is being tested?
- NatraCure Cold Therapy gloves and socks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion criteria: (i) aged 7-18 years; the lower age limit of 7 years was selected to ensure reliable completion of the self-report pain and quality-of-life instruments used in the study, (ii) receiving VCR therapy, (iii) diagnosed with leukemia, medulloblastoma, rhabdomyosarcoma, or Wilms tumor, (iv) able to speak and understand Turkish, (v) receiving initial treatment, and (vi) provision of written informed consent by legal guardians and assent from children.
Exclusion criteria: Risk factors for peripheral neuropathy were considered exclusion criteria (Kandula et al., 2016; Smith et al., 2021; van de Velde et al., 2017). Risk factor criteria were: (i) receiving a dose of VCR >2 mg/m2, (ii) receiving VCR and azole antifungal treatment simultaneously, (iii) a hematological malignancy with neurological disease, (iv) a history of peripheral neuropathy, (v) diabetes, or (vi) self-reported cold sensitivity. Additionally, children who received chemotherapy or other treatments via the peripheral veins of the hands or feet were not included, as cold application was contraindicated in these cases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cold Therapy on Peripheral Neuropathy: A Pilot Randomized Controlled Trial
This study examines the feasibility, acceptability, and efficacy of cold therapy on vincristine-induced peripheral neuropathy (VIPN) in pediatric patients with cancer.
Vincristine (VCR) is one of the most used vinca alkaloid chemotherapy in pediatric oncology patients. It leads to symptoms of peripheral neuropathy, numbness in the hands and feet, tingling, muscle/joint pain, burning sensation, decreased peripheral reflexes, and constipation. These symptoms negatively affect the daily life and quality of life of children. Therefore, it is essential to managing peripheral neuropathy. We aim to decrease the level of VIPN and pain and improve patients' quality of life.
Unfortunately, the neurotoxicity mechanisms of vinca alkaloids are not well known, which is one of the significant limitations in developing effective treatments to prevent VIPN among pediatric oncology patients. We were unable to locate a randomized controlled trial that has evaluated the effectiveness, tolerability, and acceptability of cold therapy on VIPN for pediatric oncology patients. Our study findings will be the first in Turkish national and international literature, and we believe that our results will provide evidence for clinical nursing practice.
Read the detailed description
An estimated 400,000 children and adolescents aged 0-19 years are diagnosed with cancer each year. More than 80% of children with cancer are cured in high-income countries, where comprehensive care is generally available, whereas survival remains below 30% in some low- and middle-income countries. Considering the global burden of childhood cancer, it is important to characterize the long-term adverse effects of cancer treatment and to develop strategies for their assessment, monitoring, prevention, and management.
Many chemotherapy agents can cause acute and chronic injury and dysfunction of the peripheral nervous system, termed chemotherapy-induced peripheral neuropathy (CIPN). CIPN is an important treatment-related complication and may affect sensory, motor, and autonomic functions. Peripheral nerve toxicity has been associated with several classes of chemotherapy, including vinca alkaloids, platinum compounds, taxanes, epothilones, bortezomib, and thalidomide. Acute CIPN may develop during chemotherapy and may necessitate dose reduction or treatment discontinuation. Reported CIPN incidence varies considerably according to patient characteristics, treatment regimens, and assessment methods. Common manifestations in children and adolescents include numbness, tingling, neuropathic pain in the upper and lower extremities, weakness, reduced ankle dorsiflexion, foot drop, and impaired balance. These symptoms and associated functional impairments may persist beyond completion of cancer treatment.
Vincristine (VCR) is a vinca alkaloid commonly used in pediatric oncology and is included in chemotherapy regimens for acute lymphoblastic leukemia, lymphomas, neuroblastoma, sarcomas, and central nervous system tumors. Vincristine-induced peripheral neuropathy (VIPN) is characterized by autonomic, sensory, and motor manifestations. Reported rates of VIPN vary substantially, partly because of differences in assessment methods. VIPN symptoms may develop after only a few VCR administrations and can include paresthesia, constipation, muscle weakness, areflexia, neuropathic pain, and sensory loss.
Management of VIPN primarily focuses on symptoms and may include medications used for neuropathic pain. VCR dose reduction or treatment interruption may be required in clinically significant cases, potentially limiting optimal cancer treatment. VIPN and associated neuropathic pain may negatively affect quality of life (QoL) during and after cancer treatment.
Both pharmacological and non-pharmacological approaches have been investigated for the management of peripheral neuropathy. However, the mechanisms underlying chemotherapy-related neurotoxicity are not fully understood, limiting the development of effective strategies for preventing VIPN in pediatric oncology patients. Cryotherapy has been investigated as a potential approach for preventing chemotherapy-induced peripheral neuropathy. Its proposed mechanism involves local vasoconstriction, which may reduce blood flow and consequently decrease chemotherapy exposure in cooled peripheral tissues. Potential limitations of cryotherapy include cold-related skin injury, discomfort or intolerance, practical difficulties with administration, and uncertainty regarding its effectiveness.
Although cryotherapy has been investigated for chemotherapy-induced peripheral neuropathy in adults, evidence regarding its use in children and adolescents with cancer is limited. Further research is therefore needed to evaluate its effectiveness, tolerability, and feasibility in pediatric oncology populations. This study aims to evaluate the effectiveness, tolerability, and acceptability of cold therapy for VIPN among pediatric oncology patients in Turkey.
- Conditions
- Peripheral Neuropathy
- Being tested
- NatraCure Cold Therapy gloves and socks
- 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.
NatraCure Cold Therapy gloves and socksOther
These gloves and socks will be adjusted and tied to the child's wrists and ankles. There are sizes suitable for all ages and the dimensions of the gloves and socks can be adjusted with a snap fastener. The gloves and socks contain a soft Lycra lining and four inner gel cold packs to ensure full length cold therapy treatments. When the children wear these gloves and socks, they can still move their fingers and toes easily. In addition, it is a great advantage that the iced gel packs do not touch the child's skin directly.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Children in the control group received standard care with no additional intervention for VIPN prevention. Standard care included gabapentin (5-10 mg/kg/day in 2-3 divided doses, titrated up to 50 mg/kg/day as clinically indicated) and vitamin B6 (150 mg/m²/day in 2 divided doses), according to institutional protocol. Before the first VCR dose, pain and VIPN were assessed using the Wong-Baker FACES® Pain Rating Scale and NCI CTCAE Peripheral Neuropathy Scale and were assessed weekly thereafter. QoL was assessed monthly using the child self-report PedsQL 3.0 Cancer Module. No pre-VCR QoL assessment was performed; thus, the first PedsQL assessment was the first monthly follow-up rather than a true baseline. Assessments were interviewer-administered by the research assistant. VCR was administered according to institutional protocol. Final pain and VIPN were assessed 1 week after the final VCR dose. |
| Cold Therapy/Intervention Group | Experimental | In addition to standard care, children in the intervention group received cold therapy during vincristine (VCR) administration using NatraCure Cold Therapy gloves and socks containing gel packs stored at -18°C to -20°C. Gloves and socks were applied 5 min before VCR administration, maintained throughout the infusion, and continued for 5 min afterward (approximately 15 min/session). Gel packs were replaced every 5 min to maintain cooling. Children were monitored for cold-related adverse effects or intolerance, and the intervention was discontinued if necessary. Pain and VIPN were assessed before the first VCR dose and weekly thereafter using the Wong-Baker FACES® Pain Rating Scale and NCI CTCAE Peripheral Neuropathy Scale. Quality of life was assessed monthly using the PedsQL 3.0 Cancer Module; no pre-VCR baseline QoL assessment was performed. Final pain and VIPN outcomes and satisfaction were assessed 1 week after the final VCR dose. Receives: Other: NatraCure Cold Therapy gloves and socks |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Cancer Institute Common Terminology Criteria for Adverse Events v5 Peripheral Neuropathy Scale
The NCI CTCAE version 5.0 (ctep.cancer.gov) includes toxicity criteria for adverse events such as peripheral sensory and motor neuropathy, constipation, and neuralgia. The grading scale, used by health professionals is from 0-5, with 0=no toxicity and 5=death. In this study, a research assistant (PhD student in pediatric nursing) responsible for data collection will be trained to perform CTCAE scoring, review all medical records, and assign CTCAE version 5.0 sensory and motor scores according to the published criteria based on clinician documentation of signs and symptoms.
Measured: Before starting each VCR application, the child's VIPN in the last week post the previous application will be evaluated. One week after the last VCR dose, the child's VIPN will be evaluated.
Secondary outcomes (1)
Wong-Baker FACES® Pain Rating Scale
This scale consists of six facial expressions. Facial expressions range from 0 points "no pain-very happy" to 10 points "unbearable pain-crying" (Wong-Baker FACES Foundation, 2016). The self-report scale is commonly used for children aged 3-18 (Martin et al., 2018). It has good validity and reliability for measuring pain intensity (Ball et al., 2017), and is psychometrically appropriate and widely used in clinical practice (Stinson et al., 2006). The psychometric properties of this scale are also suitable for evaluation by parent proxy (Schiavenato, 2008). The scale has been translated into Turkish. (Wong-Baker FACES Foundation, 2016). For the present study, the Wong-Baker FACES® scale will be used for evaluating children's self-report and parental reports of the child's pain. This pain scale is commonly used in Turkey to evaluate children's pain. It is used as a standard measurement tool in the pain assessment of children aged 3-18 in all pediatric clinics in Turkey.
Measured: Before starting each VCR application, the child's pain in the last week post the previous application will be evaluated. One week after the last VCR dose, the child's pain will be evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start30 Jun 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- As the primary aim of this pilot RCT was to evaluate feasibility recruitment, retention, tolerability, acceptability, and safety rather than to test intervention effectiveness through a powered hypothesis test, the sample size was determined based on methodological recommendations for pilot studies rather than a formal hypothesis-testing framework. Previous guidance has suggested that approximately 12 participants per group may be sufficient to estimate parameters and assess feasibility in pilot research (Julious, 2005). In addition, Hertzog (2008) emphasized that pilot studies are primarily designed to evaluate feasibility and refine study procedures rather than to establish definitive effectiveness. Considering these recommendations and allowing for potential attrition, a total of 36 pediatric oncology patients (18 per group) were recruited for the present pilot study.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eysan Hanzade Umac, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488963
- Sponsor's protocol ID
- KOCUNIVERSITY
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Therapy on Peripheral Neuropathy: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06488963
- Acronym / sponsor ID
- KOCUNIVERSITY
- Conditions
- Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 5 Jul 2024 (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.
This study examines the feasibility, acceptability, and efficacy of cold therapy on vincristine-induced peripheral neuropathy (VIPN) in pediatric patients with cancer.
Vincristine (VCR) is one of the most used vinca alkaloid chemotherapy in pediatric oncology patients. It leads to symptoms of peripheral neuropathy, numbness in the hands and feet, tingling, muscle/joint pain, burning sensation, decreased peripheral reflexes, and constipation. These symptoms negatively affect the daily life and quality of life of children. Therefore, it is essential to managing peripheral neuropathy. We aim to decrease the level of VIPN and pain and improve patients' quality of life.
Unfortunately, the neurotoxicity mechanisms of vinca alkaloids are not well known, which is one of the significant limitations in developing effective treatments to prevent VIPN among pediatric oncology patients. We were unable to locate a randomized controlled trial that has evaluated the effectiveness, tolerability, and acceptability of cold therapy on VIPN for pediatric oncology patients. Our study findings will be the first in Turkish national and international literature, and we believe that our results will provide evidence for clinical nursing practice.
Detailed description
An estimated 400,000 children and adolescents aged 0-19 years are diagnosed with cancer each year. More than 80% of children with cancer are cured in high-income countries, where comprehensive care is generally available, whereas survival remains below 30% in some low- and middle-income countries. Considering the global burden of childhood cancer, it is important to characterize the long-term adverse effects of cancer treatment and to develop strategies for their assessment, monitoring, prevention, and management.
Many chemotherapy agents can cause acute and chronic injury and dysfunction of the peripheral nervous system, termed chemotherapy-induced peripheral neuropathy (CIPN). CIPN is an important treatment-related complication and may affect sensory, motor, and autonomic functions. Peripheral nerve toxicity has been associated with several classes of chemotherapy, including vinca alkaloids, platinum compounds, taxanes, epothilones, bortezomib, and thalidomide. Acute CIPN may develop during chemotherapy and may necessitate dose reduction or treatment discontinuation. Reported CIPN incidence varies considerably according to patient characteristics, treatment regimens, and assessment methods. Common manifestations in children and adolescents include numbness, tingling, neuropathic pain in the upper and lower extremities, weakness, reduced ankle dorsiflexion, foot drop, and impaired balance. These symptoms and associated functional impairments may persist beyond completion of cancer treatment.
Vincristine (VCR) is a vinca alkaloid commonly used in pediatric oncology and is included in chemotherapy regimens for acute lymphoblastic leukemia, lymphomas, neuroblastoma, sarcomas, and central nervous system tumors. Vincristine-induced peripheral neuropathy (VIPN) is characterized by autonomic, sensory, and motor manifestations. Reported rates of VIPN vary substantially, partly because of differences in assessment methods. VIPN symptoms may develop after only a few VCR administrations and can include paresthesia, constipation, muscle weakness, areflexia, neuropathic pain, and sensory loss.
Management of VIPN primarily focuses on symptoms and may include medications used for neuropathic pain. VCR dose reduction or treatment interruption may be required in clinically significant cases, potentially limiting optimal cancer treatment. VIPN and associated neuropathic pain may negatively affect quality of life (QoL) during and after cancer treatment.
Both pharmacological and non-pharmacological approaches have been investigated for the management of peripheral neuropathy. However, the mechanisms underlying chemotherapy-related neurotoxicity are not fully understood, limiting the development of effective strategies for preventing VIPN in pediatric oncology patients. Cryotherapy has been investigated as a potential approach for preventing chemotherapy-induced peripheral neuropathy. Its proposed mechanism involves local vasoconstriction, which may reduce blood flow and consequently decrease chemotherapy exposure in cooled peripheral tissues. Potential limitations of cryotherapy include cold-related skin injury, discomfort or intolerance, practical difficulties with administration, and uncertainty regarding its effectiveness.
Although cryotherapy has been investigated for chemotherapy-induced peripheral neuropathy in adults, evidence regarding its use in children and adolescents with cancer is limited. Further research is therefore needed to evaluate its effectiveness, tolerability, and feasibility in pediatric oncology populations. This study aims to evaluate the effectiveness, tolerability, and acceptability of cold therapy for VIPN among pediatric oncology patients in Turkey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- As the primary aim of this pilot RCT was to evaluate feasibility recruitment, retention, tolerability, acceptability, and safety rather than to test intervention effectiveness through a powered hypothesis test, the sample size was determined based on methodological recommendations for pilot studies rather than a formal hypothesis-testing framework. Previous guidance has suggested that approximately 12 participants per group may be sufficient to estimate parameters and assess feasibility in pilot research (Julious, 2005). In addition, Hertzog (2008) emphasized that pilot studies are primarily designed to evaluate feasibility and refine study procedures rather than to establish definitive effectiveness. Considering these recommendations and allowing for potential attrition, a total of 36 pediatric oncology patients (18 per group) were recruited for the present pilot study.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Children in the control group received standard care with no additional intervention for VIPN prevention. Standard care included gabapentin (5-10 mg/kg/day in 2-3 divided doses, titrated up to 50 mg/kg/day as clinically indicated) and vitamin B6 (150 mg/m²/day in 2 divided doses), according to institutional protocol. Before the first VCR dose, pain and VIPN were assessed using the Wong-Baker FACES® Pain Rating Scale and NCI CTCAE Peripheral Neuropathy Scale and were assessed weekly thereafter. QoL was assessed monthly using the child self-report PedsQL 3.0 Cancer Module. No pre-VCR QoL assessment was performed; thus, the first PedsQL assessment was the first monthly follow-up rather than a true baseline. Assessments were interviewer-administered by the research assistant. VCR was administered according to institutional protocol. Final pain and VIPN were assessed 1 week after the final VCR dose. |
| Cold Therapy/Intervention Group | Experimental | Other: NatraCure Cold Therapy gloves and socksIn addition to standard care, children in the intervention group received cold therapy during vincristine (VCR) administration using NatraCure Cold Therapy gloves and socks containing gel packs stored at -18°C to -20°C. Gloves and socks were applied 5 min before VCR administration, maintained throughout the infusion, and continued for 5 min afterward (approximately 15 min/session). Gel packs were replaced every 5 min to maintain cooling. Children were monitored for cold-related adverse effects or intolerance, and the intervention was discontinued if necessary. Pain and VIPN were assessed before the first VCR dose and weekly thereafter using the Wong-Baker FACES® Pain Rating Scale and NCI CTCAE Peripheral Neuropathy Scale. Quality of life was assessed monthly using the PedsQL 3.0 Cancer Module; no pre-VCR baseline QoL assessment was performed. Final pain and VIPN outcomes and satisfaction were assessed 1 week after the final VCR dose. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| NatraCure Cold Therapy gloves and socksThese gloves and socks will be adjusted and tied to the child's wrists and ankles. There are sizes suitable for all ages and the dimensions of the gloves and socks can be adjusted with a snap fastener. The gloves and socks contain a soft Lycra lining and four inner gel cold packs to ensure full length cold therapy treatments. When the children wear these gloves and socks, they can still move their fingers and toes easily. In addition, it is a great advantage that the iced gel packs do not touch the child's skin directly. | Other | Cold Therapy/Intervention Group |
Primary outcome
National Cancer Institute Common Terminology Criteria for Adverse Events v5 Peripheral Neuropathy Scale
Time frame: Before starting each VCR application, the child's VIPN in the last week post the previous application will be evaluated. One week after the last VCR dose, the child's VIPN will be evaluated.
The NCI CTCAE version 5.0 (ctep.cancer.gov) includes toxicity criteria for adverse events such as peripheral sensory and motor neuropathy, constipation, and neuralgia. The grading scale, used by health professionals is from 0-5, with 0=no toxicity and 5=death. In this study, a research assistant (PhD student in pediatric nursing) responsible for data collection will be trained to perform CTCAE scoring, review all medical records, and assign CTCAE version 5.0 sensory and motor scores according to the published criteria based on clinician documentation of signs and symptoms.
1 secondary outcome
Wong-Baker FACES® Pain Rating Scale
Time frame: Before starting each VCR application, the child's pain in the last week post the previous application will be evaluated. One week after the last VCR dose, the child's pain will be evaluated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NatraCure Cold Therapy gloves and socks in people with Peripheral Neuropathy, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Cancer Institute Common Terminology Criteria for Adverse Events v5 Peripheral Neuropathy Scale (time frame: Before starting each VCR application, the child's VIPN in the last week post the previous application will be evaluated. One week after the last VCR dose, the child's VIPN will be evaluated.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.