Clinical trial NCT04446819: Compression Gloves to Reduce Albumin-binding Paclitaxel Induced Peripheral Sensory and Motor Neurotoxicity (REMAINING)
Official title: A Multicenter Prospective Phase III Clinical Study of Reducing Albumin-binding Paclitaxel Induced Peripheral Sensory and Motor Neurotoxicity of Upper Extremities With Compression Gloves (REMAINING)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Neuropathy
Keywords: Paclitaxel
Compression gloves
Compression therapy
Neurotoxicity
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Differences in severe peripheral sensory neurotoxicity rates
timeFrame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Secondary outcomes:
measure: Differences in total peripheral sensory neurotoxicity rates
timeFrame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
measure: Differences in severe peripheral motor neurotoxicity rates
timeFrame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
measure: Differences in total peripheral motor neurotoxicity rates
timeFrame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
measure: Differences in peripheral neurotoxicity questionaire scores
timeFrame: 3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
measure: Safety of compression gloves in preventing albumin-binding paclitaxel induced neurotoxicity.
timeFrame: From date of consent to one months after Cycle 4 administration of albumin-binding paclitaxel (each cycle is 21 days).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Department of medical oncology, Fudan University Shanghai Cancer Center
name: Jian Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: