NCT05341141

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
3mo left

Started Jun 2022

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jun 2022Nov 2026

First Submitted

Initial submission to the registry

April 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

4.1 years

First QC Date

April 17, 2022

Last Update Submit

June 10, 2022

Conditions

Breast Cancer

Keywords

Chemotherapy-induced Peripheral NeuropathyAlbumin-paclitaxelCryotherapyCompression Therapydose-dense chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0

    Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0

    4 years

Secondary Outcomes (8)

  • Incidence of grade 2 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0

    4 years

  • Proportion of patients reporting level D and above based on the Patient Neurotoxicity Questionnaire (PNQ)

    4 years

  • EORTC QLQ-CIPN20

    4 years

  • Incidence and severity of other adverse events as assessed by NCI-CTCAE V5.0

    4 years

  • Total pathological complete response (tpCR) rate

    Within 2 to 4 weeks after completion of neoadjuvant therapy

  • +3 more secondary outcomes

Study Arms (2)

ddEC-ddT and cryotherapy combined with compression

EXPERIMENTAL

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.

Device: Frozen glove and sockDrug: ddEC-ddT

ddEC-ddT

OTHER

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

Drug: ddEC-ddT

Interventions

Frozen glove and sockDEVICE

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

ddEC-ddT and cryotherapy combined with compression
ddEC-ddTDRUG

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.

Also known as: Chemotherapy
ddEC-ddTddEC-ddT and cryotherapy combined with compression

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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\<1% and PR\<1%; 2) T \> 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.

You may not qualify 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, 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;
  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Zhaoqing Fan, MD

    Breast center at Peking University Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoqing Fan, MD

CONTACT

+86-10-88197838zhqfan@sina.com

Lize Wang, MD

CONTACT

+86-10-88197828lize2010@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Breast Center of Peking University Cancer Hospital

Study Record Dates

First Submitted

April 17, 2022

First Posted

April 22, 2022

Study Start

June 10, 2022

Primary Completion

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

June 13, 2022

Record last verified: 2022-06

Locations

CN(1)