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

NCT ID: NCT04446819

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-12
• Study Completion Date: 2022-06-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Compression gloves

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jian Zhang,MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of medical oncology, Fudan University Shanghai Cancer Center

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Zhang, PhD

Role: CONTACT

syner2000@163.com

86-21-64175590

Facility Contacts

Jian Zhang, PhD

Role: primary

86-21-64175590

Other Identifiers

BUAY-20-01

Identifier Type: -

Identifier Source: org_study_id