Compression Gloves to Reduce Albumin-binding Paclitaxel Induced Peripheral Sensory and Motor Neurotoxicity (REMAINING)

  • STATUS
    Recruiting
  • days left to enroll
    5
  • participants needed
    70
  • sponsor
    Fudan University
Updated on 24 January 2021
paclitaxel
neuropathy

Summary

Nanoparticle albumin-bound paclitaxel has greater efficacy and favorable safety profile than standard paclitaxel. However, rate of neuropathy caused by nanoparticle albumin-bound paclitaxel is higher than standard paclitaxel, and is one of its dose-limited toxicities. Previously, compression therapy by surgical gloves has shown effectiveness in preventing chemotherapy-induced neuropathy. We designed this multi-center prospective self-control phase III study to investigate the efficacy of compression gloves to reduce albumin-binding paclitaxel induced sensory and motor neurotoxicity of upper extremities.

Details
Condition Peripheral Neuropathy, Peripheral Neuropathy, peripheral nerve disease, peripheral nerve damage
Treatment Compression gloves
Clinical Study IdentifierNCT04446819
SponsorFudan University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients are diagnosed with pathologically confirmed solid tumors
Patients are about to receive albumin-binding paclitaxel monotherapy (at least 4 cycles anticipated) by physicians' choice
Patients should have baseline Grade 0 peripheral sensory and motor neurotoxicity (NCI-CTCAE 5.0)
Eastern Cooperative Oncology Group performance status 1
Biochemical tests within 7 days before inclusion should meet the following criteria
Hemoglobin 90g/L, white blood cell count 3500/mm^3, neutrophil 1500/mm^3 and platelet 75000/mm^3 with no blood transfusion or hematopoietic colony-stimulating factors in the past 14 days
Creatinine 1.5 times upper limit of normal (ULN)
Liver function: For patients without liver metastasis, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) 1.5 times ULN, and total bilirubin 1.25 times ULN. For patients with liver metastasis, ALT, AST and ALP 5 times ULN and total bilirubin 1.5 times ULN
Life expectancy 12 weeks
No history of severe diseases in important organs including heart, lung, liver, and kidney
Willingness to sign a written informed consent
Willingness to adhere to dose and visit schedules
Women of child-bearing ages should be willing to take birth control methods during treatment and within 8 weeks after trial, and pregnancy test (blood or urine) within 14 days before inclusion should be negative (if positive, ultrasound should be performed to rule out pregnancy). Male patients should be willing to take birth control methods during treatment and within 8 weeks after trial or be sterilized by surgery

Exclusion Criteria

Patients with uncontrolled and severe infection
Patients with meningeal metastasis, symptomatic brain metastasis, spinal cord compression, or new discovery of brain or pia mater diseases during screening. Patients who finish brain local control treatment, manifest stable symptoms and without brain hemorrhage in radiological screening can be included in the trial
Investigators decide the patient unsuitable for the trial
Elimination Criteria
Patients have allergy to albumin-binding paclitaxel and are unable to finish 4 cycles of treatment
Patients are unable to finish 4 cycles of albumin-binding paclitaxel monotherapy due to intolerable toxicities even after twice dose reduction. If due to toxicity of peripheral neurotoxicity, evaluations should be performed and recorded for further case study
Patients are unable to finish 4 cycles of albumin-binding paclitaxel monotherapy because of change of regimen due to progression or death
Patients require to quit
Patients are found to have situations that are not suitable for the trial after inclusion
Patients' hands are unfit for the compression gloves used in the trial (too big or too small)
Any situations that investigators believe necessary for patients to quit the trial
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