Clinical trial NCT05341141: Effectiveness of Cryotherapy Combined With Compression Therapy for Preventing Chemotherapy-induced Peripheral Neuropathy
Official title: Effectiveness of Cryotherapy Combined With Compression Therapy in Preventing Albumin-paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Chemotherapy-induced Peripheral Neuropathy
Albumin-paclitaxel
Cryotherapy
Compression Therapy
dose-dense chemotherapy
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2022-04-22
Enrollment: 102
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Female patients aged from 20 to 70 years old;
2. Histologically confirmed as invasive breast cancer;
3. HER-2 negative (defined by IHC 0 or 1+ ,or FISH negative);
4. Participants who meet any of the following conditions: 1) T \> 2 cm, ER\<1% and PR\<1%; 2) T \> 2 cm, ER≥1% and biopsy pathology (FNAB or CNB) diagnosed regional lymph node metastasis;
5. Without any previous treatment;
6. ddEC-ddT neoadjuvant chemotherapy is planned;
7. Participants must have at least one measurable disease according to RECIST 1.1;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
9. LVEF ≥ 50%;
10. The ECG results are judged to be almost normal or normal, or the investigator judges that the abnormalities are not clinically significant;
11. Bone marrow function: absolute neutrophil counts (ANC) ≥ 1.5x10\^9/L, platelets ≥ 100x10\^9/L, hemoglobin ≥ 90g/L;
12. Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are both ≤2.5 ULN; serum total bilirubin and serum creatinine are both ≤ 1.5 ULN;
13. Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.

Exclusion Criteria:

1. Breast cancer with distant metastasis;
2. A history of other malignancies;
3. In the past or present, participants with sensory or motor neurological diseases;
4. Participants who are known to be allergic to the active or other components of the study treatment;
5. Cerebral thrombosis is present;
6. In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate \> 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 \[Mobitz 2\] atrioventricular block or third-degree atrioventricular block); 2) Angina pectoris requiring anti-angina medication; 3) Clinically significant valvular heart disease; 4) ECG showing transmural myocardial infarction; 5) ncontrolled hypertension (eg systolic blood pressure \> 180mm Hg or diastolic blood pressure \> 100mmHg); 6) Myocardial infarction; 7) Congestive heart failure;
7. Participants have the following serious illnesses or medical conditions, including but not limited: 1) History of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2) Active uncontrolled infection; 3) Active pepticulcer, unstable diabetes;
8. Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation;
9. Participants who were judged by the investigator to be unsuitable for this study.

Primary outcomes:
measure: Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
timeFrame: 4 years
Secondary outcomes:
measure: Incidence of grade 2 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
timeFrame: 4 years
measure: Proportion of patients reporting level D and above based on the Patient Neurotoxicity Questionnaire (PNQ)
timeFrame: 4 years
measure: EORTC QLQ-CIPN20
timeFrame: 4 years
measure: Incidence and severity of other adverse events as assessed by NCI-CTCAE V5.0
timeFrame: 4 years
measure: Total pathological complete response (tpCR) rate
timeFrame: Within 2 to 4 weeks after completion of neoadjuvant therapy
measure: Breast pathological complete response (bpCR) rate
timeFrame: Within 2 to 4 weeks after completion of neoadjuvant therapy
measure: Objective response rate (ORR)
timeFrame: After the last dose to before surgery or within 28 days
measure: Invasive disease-free survival (IDFS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Breast center at Peking University Cancer Hospital
name: Zhaoqing Fan, MD
role: PRINCIPAL_INVESTIGATOR
References: