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Simple Surgical Glove Compression to Prevent Chemotherapy-Induced Peripheral Neuropathy

ConditionsBreast CancerChemotherapy Induced Peripheral Neuropathy (CIPN)Neoadjuvant Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJinsong Lu

About this trial

To evaluate the preventive efficacy of a simple surgical glove compression technique in reducing the incidence and severity of Chemotherapy Induced Peripheral Neuropathy among patients receiving chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Histologically confirmed primary invasive breast cancer;

Planned to receive ≥ 8 weeks of weekly neoadjuvant chemotherapy (utidelone plus cisplatin);

ECOG performance status: 0-1;

Disqualifiers

Distant metastasis;

Presence of sensory or motor neurological disorders, or symptoms related to peripheral neuropathy with CTCAE grade ≥ 2, or currently receiving medication for peripheral neuropathy;

Conditions affecting limb function;

Known allergy to glove materials (e.g., latex)

Trial design

Design model

Single group

Treatments tested in this trial

  • Simple Surgical Glove Compression Technique

    Procedure/Surgery

    Patients will wear surgical gloves of smaller size than the patient's hand, on the dominant hand from 15 minutes before the start of each neoadjuvant chemotherapy infusion until 15 minutes after the end of infusion (total of 90 minutes). The non-dominant hand will serve as the untreated control.

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: Group with surgical glove compression applied to the dominant handExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in the functional assessment of cancer therapy/gynaecologic oncology group-neurotoxicity (FACT/GOG-Ntx) subscale score(range:-44to44; higher scores indicate better neurotoxicity-related quality of life).

Time frame
From baseline (prior to neoadjuvant chemotherapy) to after 8 weeks of neoadjuvant chemotherapy in breast cancer

Secondary outcomes

1

Change in scores and the sum score of four hand-related items of the FACT/GOG-Ntx subscale (range: -16to+16; higher scores indicate better neurotoxicity-related quality of life).

Time frame
From baseline (prior to neoadjuvant chemotherapy) to after 8 weeks of neoadjuvant chemotherapy in breast cancer
2

The overall change in the FACT/GOG-Ntx subscale score (range: -44to44; higher scores indicate better neurotoxicity-related quality of life)

Time frame
From baseline to the end of neoadjuvant chemotherapy and 6 months after completion of neoadjuvant chemotherapy
3

Incidence of CIPN as determined by changes in tactile sensitivity assessed with the Semmes-Weinstein monofilament test

Time frame
From baseline to the end of and 6 months after completion of neoadjuvant chemotherapy
4

Incidence of CIPN according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
From baseline to the end of and 6 months after completion of neoadjuvant chemotherapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinsong Lu

Lead sponsor

RenJi Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: