Breast Cancer, Chemotherapy Induced Peripheral Neuropathy (CIPN), Neoadjuvant Therapy
Conditions
Keywords
Utidelone, CIPN, Neoadjuvant chemotherapy
Brief summary
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.
Interventions
PROCEDURESimple Surgical Glove Compression Technique
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.
Sponsors
Jinsong Lu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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;
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | From baseline (prior to neoadjuvant chemotherapy) to after 8 weeks of neoadjuvant chemotherapy in breast cancer |
Secondary
| Measure | Time frame |
|---|---|
| The overall change in the FACT/GOG-Ntx subscale score (range: -44to44; higher scores indicate better neurotoxicity-related quality of life) | From baseline to the end of neoadjuvant chemotherapy and 6 months after completion of neoadjuvant chemotherapy |
| Incidence of CIPN as determined by changes in tactile sensitivity assessed with the Semmes-Weinstein monofilament test | From baseline to the end of and 6 months after completion of neoadjuvant chemotherapy |
| 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). | From baseline (prior to neoadjuvant chemotherapy) to after 8 weeks of neoadjuvant chemotherapy in breast cancer |
| Changes in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores (range: -12to12, higher scores on functional and global health domains indicate better quality of life,; -84to84; while higher | At baseline (prior to initiation of neoadjuvant chemotherapy), at 8 weeks of neoadjuvant chemotherapy, at 2 weeks after completion of neoadjuvant chemotherapy, and at 6 months after completion of neoadjuvant chemotherapy. |
| Changes in the maximum width and height of the lunula of each finger | At baseline (prior to initiation of neoadjuvant chemotherapy), at 8 weeks of neoadjuvant chemotherapy, at 2 weeks after completion of neoadjuvant chemotherapy, and at 6 months after completion of neoadjuvant chemotherapy. |
| Incidence of CIPN according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | From baseline to the end of and 6 months after completion of neoadjuvant chemotherapy |
Countries
China
Contacts
Primary ContactJinsong Lu, M.D.
Outcome results
None listed