Clinical trial · Interventional
Effectiveness of Cryotherapy Combined With Compression Therapy for Preventing Chemotherapy-induced Peripheral Neuropathy
Effectiveness of Cryotherapy Combined With Compression Therapy in Preventing Albumin-paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
NCT05341141CI-TRIAL-00059039recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ddEC-ddT | Drug | — | UNRESOLVED |
| Frozen glove and sock | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ddEC-ddT and cryotherapy combined with compression
- description
- 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.
- interventionNames
- Device: Frozen glove and sock
- Drug: ddEC-ddT
- type
- OTHER
- label
- ddEC-ddT
- description
- ddEC-ddT will be administered without cryotherapy combined with compression.
- interventionNames
- Drug: ddEC-ddT
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.