Peripheral Neuropathy Trial, Recruiting NCT07638774 Sponsor: Fudan University Condition: Peripheral Neuropathy
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Peripheral Neuropathy Trial, Recruiting

NCT07638774
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women between 18 and 75 years of age
  • People who have been diagnosed with breast cancer that has spread or cannot be surgically removed, confirmed through a tissue or cell sample
  • People who are planned to receive at least 2 cycles of a treatment regimen that includes the drug UTD1
  • People who have little to no nerve problems in their hands, feet, or limbs before starting the trial (below a certain threshold on a standard medical scale)
  • People who are generally well enough to carry out daily activities with little or no limitation (as measured by a standard health scale)
  • People whose blood counts and organ function meet specific minimum levels when tested within 7 days before joining, including healthy levels of white blood cells, platelets, and red blood cells, without having received blood transfusions or certain blood-boosting medications very recently
  • People whose kidney and liver function blood test results fall within acceptable ranges before joining
  • People who are expected to live for at least 12 weeks
  • People with no history of serious heart, lung, liver, kidney, or other major organ disease
  • People who have signed a form giving their informed agreement to take part
  • People who are willing and able to follow the trial's requirements throughout
  • Women who could become pregnant must have had a negative pregnancy test within 14 days before joining, and must already be using reliable contraception and be willing to continue using it during the trial and for 8 weeks after it ends

Who may not be able to join:

  • People who have previously been treated with the drug UTD1
  • People who have a severe infection that is not under control
  • People who have cancer that has spread to the membranes around the brain or spinal cord, brain spread causing symptoms, pressure on the spinal cord, or brain or membrane involvement detected on scans at the start of the trial — though people who completed local brain treatment at least 21 days before starting and have stable symptoms with no bleeding in the brain confirmed by imaging may still be considered eligible (confirm with trial site)
  • People whose hands or feet are not suitable for wearing compression or cold gloves and socks used in the trial
  • People who are unable to complete the nerve symptom questionnaires, including those who cannot read, or who have other neurological conditions that could affect the accuracy of nerve-related assessments

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Ting Li, fudan university shanghai cancer center shanghai, China

Phone: 13816110335

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
15 March 2023
Est. completion
1 June 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Difference in the incidence of ≥ grade 2 peripheral sensory neuropathy (CTCAE 5.0) after 2 cycles of UTD1 treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov