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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Neuropathy
• Intervention / Treatment: Device: Compression gloves

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Zhang, PhD; Phone Number: 86-21-64175590; Email: syner2000@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Jian Zhang, PhD; Phone Number: 86-21-64175590

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort; Patients diagnosed with solid tumors who are about to received albumin-binding paclitaxel monotherapy are recruited. Dominant hands and non-dominant hands are treated with small-size compression gloves and suitable-size compression gloves, respectively, during the administration of albumin-binding paclitaxel.	Device: Compression gloves; Patients wear small-size compression gloves (one or two size smaller than suitable size) for dominant hands and suitable-size compression gloves for non-dominant hands for 90 minutes during the administration of albumin-binding paclitaxel (start from 30 minutes before albumin-binding paclitaxel infusion).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in severe peripheral sensory neurotoxicity rates	Differences in peripheral sensory neurotoxicity (NCI-CTCAE Grade 2-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.	3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in total peripheral sensory neurotoxicity rates	Differences in total peripheral sensory neurotoxicity (NCI-CTCAE Grade 1-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.	3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Differences in severe peripheral motor neurotoxicity rates	Differences in severe peripheral motor neurotoxicity (NCI-CTCAE Grade 2-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.	3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Differences in total peripheral motor neurotoxicity rates	Differences in total peripheral motor neurotoxicity (NCI-CTCAE Grade 1-5) rates between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.	3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Differences in peripheral neurotoxicity questionaire scores	Differences in peripheral neurotoxicity questionaire scores between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.	3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Safety of compression gloves in preventing albumin-binding paclitaxel induced neurotoxicity.	Adverse events related to compression gloves intervention are collected.	From date of consent to one months after Cycle 4 administration of albumin-binding paclitaxel (each cycle is 21 days).

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Jian Zhang, PhD, Department of Medical Oncology, Fudan University Shanghai Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Paclitaxel; Neurotoxicity; Compression therapy; Compression gloves
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Nervous System Diseases; Neuromuscular Diseases; Poisoning; Peripheral Nervous System Diseases; Neurotoxicity Syndromes
• Other Study ID Numbers: BUAY-20-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No