Breast CancerNCT05341141
Effectiveness of Cryotherapy Combined With Compression Therapy for Preventing Chemotherapy-induced Peripheral Neuropathy
A study testing Frozen glove and sock and ddEC-ddT in people with Breast Cancer, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Frozen glove and sock and ddEC-ddT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2022to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Zhaoqing Fan, +86-10-88197838, zhqfan@sina.com
Zhaoqing Fan, MD
About this study
Official title: Effectiveness of Cryotherapy Combined With Compression Therapy in Preventing Albumin-paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
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.
Read the 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
- Being tested
- Frozen glove and sock, ddEC-ddT
- Keywords
- Chemotherapy-induced Peripheral Neuropathy, Albumin-paclitaxel, Cryotherapy, Compression Therapy, dose-dense chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frozen glove and sockDevice
Preparation of frozen glove and sock: 4℃ for 3 hours.
ddEC-ddTDrug
Also called Chemotherapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Frozen glove and sock; Drug: ddEC-ddT |
| ddEC-ddT | Other | ddEC-ddT will be administered without cryotherapy combined with compression. Receives: Drug: ddEC-ddT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Secondary outcomes (8)
Incidence of grade 2 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
Incidence of grade 2 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
Measured: 4 years
Proportion of patients reporting level D and above based on the Patient Neurotoxicity Questionnaire (PNQ)
PNQ scale ranges from scores A to E; with scoring of A being not affected neuropathy, and E with the worst neuropathy.
Measured: 4 years
EORTC QLQ-CIPN20
The EORTC QLQ-CIPN20 is a fairly new 20-item questionnaire evaluating various aspects of CIPN. It has three subscales assessing sensory (nine items), motor (eight items), and autonomic (three items) symptoms and functioning with each item measured on an ordinal 1-4 scale (1, not at all; 4, very much).
Measured: 4 years
Incidence and severity of other adverse events as assessed by NCI-CTCAE V5.0
Incidence and severity of other adverse events as assessed by NCI-CTCAE V5.0
Measured: 4 years
Total pathological complete response (tpCR) rate
Total pathological complete response (tpCR) was defined as the absence of invasive lesions in the breast and axillary lymph nodes (ypT0/is ypN0). The tpCR rate is the percentage of participants with tpCR.
Measured: Within 2 to 4 weeks after completion of neoadjuvant therapy
Breast pathological complete response (bpCR) rate
Breast pathological complete response (bpCR) was defined as no invasive carcinoma in the breast (ypT0/is). The bpCR rate is the percentage of participants with bpCR.
Measured: Within 2 to 4 weeks after completion of neoadjuvant therapy
Objective response rate (ORR)
The number of participants who achieved complete response and partial response at the end of neoadjuvant chemotherapy as a percentage of the overall evaluable participants.
Measured: After the last dose to before surgery or within 28 days
Invasive disease-free survival (IDFS)
Invasive disease free survival was defined as the time from enrollment until the date of first occurrence of one of the following events: invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence (including first metastasis), invasive contralateral breast cancer, second primary invasive cancer (nonbreast, not including squamous or basal cell skin cancers, or new in situ carcinomas of any site), or death from any cause.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start10 Jun 2022
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Tao OUYANG, Peking University
- Investigators
- Zhaoqing Fan, MD, Principal investigator, Breast center at Peking University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341141
- Sponsor's protocol ID
- BC-P30(FZQ)
- Status last verified
- Jun 2022
- First submitted
- 17 Apr 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cryotherapy Combined With Compression Therapy in Preventing Albumin-paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05341141
- Acronym / sponsor ID
- BC-P30(FZQ)
- Conditions
- Breast Cancer
- Keywords
- Chemotherapy-induced Peripheral Neuropathy, Albumin-paclitaxel, Cryotherapy, Compression Therapy, dose-dense chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ddEC-ddT and cryotherapy combined with compression | Experimental | Device: Frozen glove and sock, Drug: ddEC-ddTCryotherapy 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. |
| ddEC-ddT | Other | Drug: ddEC-ddTddEC-ddT will be administered without cryotherapy combined with compression. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frozen glove and sockPreparation of frozen glove and sock: 4℃ for 3 hours. | Device | ddEC-ddT and cryotherapy combined with compression |
| ddEC-ddTAlso: ChemotherapyEpirubicin (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. | Drug | ddEC-ddT, ddEC-ddT and cryotherapy combined with compression |
Primary outcome
Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
Time frame: 4 years
Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
8 secondary outcomes
Incidence of grade 2 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0
Time frame: 4 years
Proportion of patients reporting level D and above based on the Patient Neurotoxicity Questionnaire (PNQ)
Time frame: 4 years
EORTC QLQ-CIPN20
Time frame: 4 years
Incidence and severity of other adverse events as assessed by NCI-CTCAE V5.0
Time frame: 4 years
Total pathological complete response (tpCR) rate
Time frame: Within 2 to 4 weeks after completion of neoadjuvant therapy
Breast pathological complete response (bpCR) rate
Time frame: Within 2 to 4 weeks after completion of neoadjuvant therapy
Objective response rate (ORR)
Time frame: After the last dose to before surgery or within 28 days
Invasive disease-free survival (IDFS)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhaoqing Fan, MD principal investigator
Breast center at Peking University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frozen glove and sock and ddEC-ddT in people with Breast Cancer, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaoqing Fan, MD (+86-10-88197838, zhqfan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3 and higher peripheral neuropathy as assessed by NCI-CTCAE V5.0 (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.