Using cryotherapy and compression to prevent nerve damage from chemotherapy in breast cancer patients

Effectiveness of Cryotherapy Combined With Compression Therapy in Preventing Albumin-paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients

This study is testing if using cold therapy and compression can help prevent nerve damage from chemotherapy in women with HER-2 negative breast cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 20 Years to 70 Years
• Sex: Female
• Sponsor: Peking University (Academic / other)
• Drugs / interventions: chemotherapy, cyclophosphamide
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05341141 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of combining cryotherapy with compression therapy to prevent chemotherapy-induced peripheral neuropathy in patients with HER-2 negative breast cancer. Participants will receive neoadjuvant chemotherapy consisting of dose-dense epirubicin and cyclophosphamide followed by dose-dense albumin-paclitaxel. They will be randomly assigned to either the intervention group receiving cryotherapy and compression or a control group with no intervention. The primary outcome measured will be the incidence of severe peripheral neuropathy as defined by the NCI-CTCAE V5.0 criteria.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 20 to 70 with HER-2 negative invasive breast cancer who are scheduled to receive specific neoadjuvant chemotherapy.

Not a fit: Patients with prior treatments or those with certain health conditions that disqualify them from receiving the planned chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of painful nerve damage in breast cancer patients undergoing chemotherapy.

How similar studies have performed: While the combination of cryotherapy and compression therapy is a novel approach, similar studies have shown promise in reducing chemotherapy-induced side effects.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Zhaoqing Fan, MD — Breast center at Peking University Cancer Hospital
• Study coordinator: Zhaoqing Fan, MD

Conditions Breast Cancer; Chemotherapy-induced Peripheral Neuropathy; Albumin-paclitaxel; Cryotherapy; Compression Therapy; dose-dense chemotherapy