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

NCT04446819 | Unknown

• 1 other identifier: BUAY-20-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy

Keywords

Paclitaxel; Compression gloves; Compression therapy; Neurotoxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Differences in total peripheral sensory neurotoxicity rates

  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

  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

  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

  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.

  From date of consent to one months after Cycle 4 administration of albumin-binding paclitaxel (each cycle is 21 days).

Study Arms (1)

Cohort

OTHER

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

Interventions

Compression gloves DEVICE

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).

Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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' 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Jian Zhang, PhD

  Department of medical oncology, Fudan University Shanghai Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Zhang, PhD

CONTACT

86-21-64175590; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 25, 2020
• Study Start: July 12, 2020
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)