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Cold therapy may offer relief for Chemotherapy-Induced nerve pain in children

NCT ID NCT06488963

Symptom relief Sponsor: Koç University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study tests whether wearing cooling gloves and socks can reduce nerve pain and numbness in children aged 7 to 18 who are receiving vincristine chemotherapy for cancers like leukemia and Wilms tumor. The therapy uses adjustable gel packs that wrap around the hands and feet without touching the skin directly. Researchers will measure pain levels and quality of life to see if this simple approach helps manage the side effects of treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cold therapy using NatraCure gloves and socks
What this could lead to
If effective, cold therapy could offer a simple, drug-free way to reduce nerve pain and improve quality of life for children undergoing chemotherapy.
What could go wrong
This is a small pilot study, so results may not be conclusive. Cold therapy might not reduce nerve damage, and some children may find the gloves and socks uncomfortable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

36 people

The number who actually took part.

Started

Jun 2023

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

peripheral nervous system disorder peripheral neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral neuropathy

Contacts and locations

Locations

  • Koc University

    Istanbul, Turkey (Türkiye)

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