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

Primary Purpose

Peripheral Neuropathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Compression gloves
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peripheral Neuropathy focused on measuring Paclitaxel, Compression gloves, Compression therapy, Neurotoxicity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cohort

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Safety of compression gloves in preventing albumin-binding paclitaxel induced neurotoxicity.
Adverse events related to compression gloves intervention are collected.

Full Information

First Posted
June 18, 2020
Last Updated
July 24, 2020
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04446819
Brief Title
Compression Gloves to Reduce Albumin-binding Paclitaxel Induced Peripheral Sensory and Motor Neurotoxicity (REMAINING)
Acronym
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2020 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
Keywords
Paclitaxel, Compression gloves, Compression therapy, Neurotoxicity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Compression gloves
Intervention Description
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).
Primary Outcome Measure Information:
Title
Differences in severe peripheral sensory neurotoxicity rates
Description
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.
Time Frame
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 Measure Information:
Title
Differences in total peripheral sensory neurotoxicity rates
Description
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.
Time Frame
3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Title
Differences in severe peripheral motor neurotoxicity rates
Description
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.
Time Frame
3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Title
Differences in total peripheral motor neurotoxicity rates
Description
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.
Time Frame
3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Title
Differences in peripheral neurotoxicity questionaire scores
Description
Differences in peripheral neurotoxicity questionaire scores between dominant hands and non-dominant hands after 4 cycles of albumin-binding paclitaxel monotherapy.
Time Frame
3 weeks after Cycle 4 administration and/or 1 day before Cycle 5 administration of albumin-binding paclitaxel (each cycle is 21 days).
Title
Safety of compression gloves in preventing albumin-binding paclitaxel induced neurotoxicity.
Description
Adverse events related to compression gloves intervention are collected.
Time Frame
From date of consent to one months after Cycle 4 administration of albumin-binding paclitaxel (each cycle is 21 days).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Zhang, PhD
Phone
86-21-64175590
Email
syner2000@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Zhang, PhD
Organizational Affiliation
Department of medical oncology, Fudan University Shanghai Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhang, PhD
Phone
86-21-64175590

12. IPD Sharing Statement

Plan to Share IPD
No

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

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