BridgeMD
Tests treatment safety and results for Breast Cancer
Official title Effectiveness of Cryotherapy Combined With Compression Therapy for Preventing Chemotherapy-induced Peripheral Neuropathy
ClinicalTrials.gov ID: NCT05341141
What this study is testing
What is ddEC-ddT?
ddEC-ddT is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as Chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 70, women only
You may be able to join if
- Female patients aged from 20 to 70 years old;
- Histologically confirmed as invasive breast cancer;
- HER-2 negative (defined by IHC 0 or 1+ ,or FISH negative);
- Participants who meet any of the following conditions: 1) T \> 2 cm, ER\ 2 cm, ER≥1% and biopsy pathology (FNAB or CNB) diagnosed regional lymph node...
- Without any previous treatment;
You likely can't join if
- Breast cancer with distant metastasis;
- A history of other malignancies;
- In the past or present, participants with sensory or motor neurological diseases;
- Participants who are known to be allergic to the active or other components of the study treatment;
- Cerebral thrombosis is present;
- In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) High-risk uncontrolled arrhythmia...
See the full eligibility criteria
- Female patients aged from 20 to 70 years old;
- Histologically confirmed as invasive breast cancer;
- HER-2 negative (defined by IHC 0 or 1+ ,or FISH negative);
- Participants who meet any of the following conditions: 1) T \> 2 cm, ER\ 2 cm, ER≥1% and biopsy pathology (FNAB or CNB) diagnosed regional lymph node metastasis;
- Without any previous treatment;
- ddEC-ddT neoadjuvant chemotherapy is planned;
- Participants must have at least one measurable disease according to RECIST 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- LVEF ≥ 50%;
- The ECG results are judged to be almost normal or normal, or the investigator judges that the abnormalities are not clinically significant;
- Bone marrow function: absolute neutrophil counts (ANC) ≥ 1.5x10\^9/L, platelets ≥ 100x10\^9/L, hemoglobin ≥ 90g/L;
- 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;
- Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form.
- Breast cancer with distant metastasis;
- A history of other malignancies;
- In the past or present, participants with sensory or motor neurological diseases;
- Participants who are known to be allergic to the active or other components of the study treatment;
- Cerebral thrombosis is present;
- 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...
- 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...
- Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation;
- Participants who were judged by the investigator to be unsuitable for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.