This is a prospective, multi-center, randomized study designed to evaluate the clinical efficacy of cryotherapy combined with compression therapy in preventing albumin-paclitaxel induced peripheral neuropathy.
All HER-2 negative breast cancer patients received neoadjuvant chemotherapy with four cycles of dose-dense epirubicin and cyclophosphamide (ddEC) followed by four cycles of dose-dense albumin-paclitaxel (ddT). The patients were randomly assigned in a 1:1 ratio to receive cryotherapy combined with compression or no intervention. The primary endpoint was incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
102
Preparation of frozen glove and sock: 4℃ for 3 hours.
Epirubicin (E) 90\~100mg/m\^2, i.v., d1 + cyclophosphamide (C) 600 mg/m\^2, i.v., d1, q2w, for 4 cycles followed by albumin-paclitaxel (T) 260 mg/m\^2, i.v., d1, q2w, for 4 cycles.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
Time frame: 4 years
Incidence of grade 2 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
Incidence of grade 2 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
Time frame: 4 years
Proportion of patients reporting level D and above based on the Patient Neurotoxicity Questionnaire (PNQ)
PNQ scale ranges from scores A to E; with scoring of A being not affected neuropathy, and E with the worst neuropathy.
Time frame: 4 years
EORTC QLQ-CIPN20
The EORTC QLQ-CIPN20 is a fairly new 20-item questionnaire evaluating various aspects of CIPN. It has three subscales assessing sensory (nine items), motor (eight items), and autonomic (three items) symptoms and functioning with each item measured on an ordinal 1-4 scale (1, not at all; 4, very much).
Time frame: 4 years
Incidence and severity of other adverse events as assessed by NCI-CTCAE V5.0
Incidence and severity of other adverse events as assessed by NCI-CTCAE V5.0
Time frame: 4 years
Total pathological complete response (tpCR) rate
Total pathological complete response (tpCR) was defined as the absence of invasive lesions in the breast and axillary lymph nodes (ypT0/is ypN0). The tpCR rate is the percentage of participants with tpCR.
Time frame: Within 2 to 4 weeks after completion of neoadjuvant therapy
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Breast pathological complete response (bpCR) rate
Breast pathological complete response (bpCR) was defined as no invasive carcinoma in the breast (ypT0/is). The bpCR rate is the percentage of participants with bpCR.
Time frame: Within 2 to 4 weeks after completion of neoadjuvant therapy
Objective response rate (ORR)
The number of participants who achieved complete response and partial response at the end of neoadjuvant chemotherapy as a percentage of the overall evaluable participants.
Time frame: After the last dose to before surgery or within 28 days
Invasive disease-free survival (IDFS)
Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause.
Time frame: 3 years