Effectiveness of Cryotherapy Combined With Compression Therapy for Preventing Chemotherapy-induced Peripheral Neuropathy

NCT ID: NCT05341141

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2026-11-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ddEC-ddT and cryotherapy combined with compression

Cryotherapy will be applied using a frozen glove and sock for 15 minutes before, during and 15 minutes after each albumin-paclitaxel infusion. Compression therapy will be applied using a surgical glove for 30 minutes before, during and 30 minutes after each albumin-paclitaxel infusion.

Group Type: EXPERIMENTAL

Frozen glove and sock

Intervention Type: DEVICE

Preparation of frozen glove and sock: 4℃ for 3 hours.

ddEC-ddT

Intervention Type: DRUG

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.

ddEC-ddT

ddEC-ddT will be administered without cryotherapy combined with compression.

Group Type: OTHER

ddEC-ddT

Intervention Type: DRUG

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.

Interventions

Frozen glove and sock

Preparation of frozen glove and sock: 4℃ for 3 hours.

Intervention Type: DEVICE

ddEC-ddT

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.

Intervention Type: DRUG

Other Intervention Names

Chemotherapy

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Tao OUYANG

Director of Breast Center of Peking University Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhaoqing Fan, MD

Role: PRINCIPAL_INVESTIGATOR

Breast center at Peking University Cancer Hospital

Locations

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhaoqing Fan, MD

Role: CONTACT

zhqfan@sina.com

+86-10-88197838

Lize Wang, MD

Role: CONTACT

lize2010@163.com

+86-10-88197828

Facility Contacts

Zhaoqing Fan

Role: primary

zhqfan@sina.com

+86-10-88197838

Other Identifiers

BC-P30(FZQ)

Identifier Type: -

Identifier Source: org_study_id