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Scientists probe skin blood flow to unravel chemo nerve pain mystery

NCT ID NCT04415892

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how certain substances applied to the skin affect blood flow in people with nerve pain caused by chemotherapy. Researchers will compare healthy volunteers and patients to better understand the pain. The goal is to learn more about the condition, not to test a new treatment.

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

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Dec 2026

An estimate. End dates often move.

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 Healthy volunteers: 1. Subject is a white male ≥18 and ≤45 years of age. 2. Subject is a non-smoker for at least 6 months prior to the start of the study. 3. Subject has a body mass index between 18-30 kg/m². 4. Subject is judged to be in good health on the basis of medical history, physical examination and vital signs. 5. Subject understands the procedures and agrees to participate in the study by giving written informed consent. 6. Subject is matched to the patient groups for sex, age and BMI (only part II). Inclusion Criteria Patients of Part II: 1. Subject is a white male or female ≥18 and ≤70 years of age. 2. Subject is a non-smoker for at least 6 months prior to the start of the study. 3. Subject has a BMI between 18-35 kg/m². 4. Subject has a history of treatment with one of the following chemotherapeutic agents: * Paclitaxel * Oxaliplatin 5. Subject suffers from peripheral neuropathy grade 1, 2 or 3 according to the Total Neuropathy Score (clinical version). Grade 1 correlates to a score of 1-7, grade 2 to a score of 8-14 and grade 3 to a score of 15-21(10-12). 6. Subject suffers from neuropathic symptoms in the upper limbs. 7. Discontinuation or termination of therapy with the chemotherapeutic agent occurred \>1 month and \< 1 year ago. 8. Subject understands the procedures and agrees to participate in the study by giving written informed consent. Inclusion Criteria for patients of Part III 1. Subject is a white male or female ≥18 and ≤75 years of age. 2. Subject is a non-smoker for at least 6 months prior to the start of the study. 3. Subject has a BMI between 18-35 kg/m². 4. Subject will receive treatment with paclitaxel or oxaliplatin in the near future. 5. Subject understands the procedures and agrees to participate in the study by giving written informed consent. Exclusion Criteria: 1. Subject has eczema, scleroderma, psoriasis, dermatitis, or keloids, tumors, ulcers, burns, flaps or grafts on their fingers or any other abnormality of the skin which, in the opinion of the investigator may interfere with the study assessments. 2. Subject has excessive hair growth on the fingers. 3. Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study. 4. Subject has a history of significant severe (drug) allergies. 5. Subject uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study. 6. Subject currently uses lotions, oils, depilatory preparations, makeup, or other topical treatments on the fingers on a regular basis which cannot be discontinued for the duration of the study. 7. Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a regular user of any illicit drugs, or has a history of drug (including alcohol) abuse. 8. Subject is unable to refrain from drinking caffeinated beverages (e.g. coffee, tea, cola, …) 24 hours prior to each study visit. Subject is unable to limit their intake of caffeinated beverages to ≤4 cups a day throughout the study. 9. Subject has any of the following vital sign measurements at screening after at least 10 minutes of supine rest: Heart Rate \<40 or \>100 beats/min, Diastolic Blood Pressure \<50 or \>90 mmHg, Systolic Blood Pressure \<90 or \>140 mmHg. 10. Subject is currently participating or has been involved in testing an investigational drug in another clinical study within the last 4 weeks. 11. Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with safe and optimal participation in the study. 12. Subject has a history of any illness or disorder which, in the investigator's opinion, might confound the results of the study. 13. Subject suffered from peripheral neuropathy prior to the chemotherapeutic treatment (Only for patients). 14. Subject has (a history of) diabetes mellitus, amyloidosis, vitamin B deficiency or any other medical disorder that, in the investigator's opinion, may cause peripheral neuropathy (only for Part II and III). 15. Subject has (a history of) a lesion in the central nervous system that is known to possibly cause neuropathic pain: e.g. spinal cord injury, infarction localized in the brainstem or thalamus, syringomyelia, multiple sclerosis, or any other disorder of the CNS that, in the investigator's opinion, may cause neuropathic pain (only for Part II and III). 16. Subject has a history of treatment with bortezomib, vincristine, or any other compound that, in the investigator's opinion, may cause neuropathic pain (only for Part II and III). 17. Subject did not develop neuropathy after treatment with epirubicine-cyclofosfamide (only for the paclitaxel group in Part III). 18. Subject has a family history of peripheral neuropathy (only for Part II and III).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • KU Leuven

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

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