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For the specific patient population studied receiving 5-Fluorouracil, epirubicin and cyclophosphamide - Docetaxel sequence (cumulative dose <300 mg / m2), using a cryoprotection has never been assessed.
The effectiveness of cryoprotection of onycholysis secondary to Docetaxel is not well established in this population (breast cancer in the adjuvant setting) and is based solely on a publication (Scotté) that does not contain the same therapeutic modalities (dose significantly higher). The few studies available have heterogeneous populations, nonrandomized, retrospective or with a small sample.
By extension to what has been observed with higher cumulative doses of docetaxel, some teams offer mittens and booties chilled to their patients, a practice that is not the subject of a national consensus.
The investigators wish to accurately assess the effectiveness of mittens and slippers chilled, their tolerance and their observance because of weak data on this specific population in the literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard cryoprotection | Active Comparator | Proposal helmet without mittens and booties |
|
| Cryoprotection with mittens and booties | Experimental | Standard cryoprotection with mittens and booties |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mittens and booties | Other |
| ||
| cooling helmet |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Occurrence of Nail Toxicity of Grade 2 of Common Toxicity Criteria for Adverse Effects V4.0 Evaluated at 8 Weeks Post Infusion of Docetaxel. | 8 weeks post infusion of docetaxel |
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Inclusion Criteria:
Exclusion Criteria:
Age below 18 years
Diseases of the scalp or whatever hair-showing against helmet or alopecia
Using pre nail resin before and per chemotherapy
mammary adenocarcinoma stage IV
Indication of docetaxel for cancer of another organ than breast
Treatment processing or programmed during chemotherapy with an innovative molecule being evaluated
Raynaud's syndrome, cold agglutinin disease, cryoglobulinemia and cryofibrinogenemia.
Uncontrolled severe arterial disease.
Presence of a device> grade 1 neuropathy before the start of chemotherapy
Patient unable to submit the protocol followed for psychological, social, family or geographical
Patient with an incompatible underlying disease or concomitant with the inclusion in the trial, whether psychiatric or somatic
Patient trust, guardianship, under legal protection measure, deprived of freedom
Male
Criteria for non randomization (before the first course of docetaxel) :
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| Name | Affiliation | Role |
|---|---|---|
| Frank PRIOU, PH | CHD Vendee La Roche sur Yon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de cancérologie de l'Ouest - Angers | Angers | 49933 | France | |||
| Centre Hospitalier de Cholet |
Of 319 enrolled participants, 280 met inclusion criteria and were randomized to treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Cryoprotection With Mittens and Booties | Standard cryoprotection with mittens and booties mittens and booties cooling helmet |
| FG001 | Standard Cryoprotection | Proposal helmet without mittens and booties cooling helmet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention-to-treat analysis. 6 patients removed from the analysis because no taxotere treatment was performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cryoprotection With Mittens and Booties | Standard cryoprotection with mittens and booties mittens and booties cooling helmet |
| BG001 | Standard Cryoprotection | Proposal helmet without mittens and booties cooling helmet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of the Occurrence of Nail Toxicity of Grade 2 of Common Toxicity Criteria for Adverse Effects V4.0 Evaluated at 8 Weeks Post Infusion of Docetaxel. | Intention-to-treat analysis. 6 patients removed from the analysis because no taxotere treatment was performed. | Posted | Count of Participants | Participants | 8 weeks post infusion of docetaxel |
|
All-Cause mortality was assessed until the last visit (i.e. Consultation 12 months after the last course of Docetaxel), on average 16.5 months
All-Cause mortality monitored/assessed. Serious and Other (Not Including Serious) Adverse Events were not assessed for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cryoprotection With Mittens and Booties | Standard cryoprotection with mittens and booties mittens and booties cooling helmet |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank PRIOU | Centre Hospitalier Départemental Vendée | 0251446161 | +33 | frank.priou@ght85.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2018 | Feb 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Other |
|
| Cholet |
| 49300 |
| France |
| CHD Vendee | La Roche-sur-Yon | 85925 | France |
| CH du Mans | Le Mans | 72000 | France |
| Centre hospitalier Bretagne Sud | Lorient | 56100 | France |
| Centre Catherine de Sienne | Nantes | 44202 | France |
| Institut de cancérologie de l'Ouest - Nantes | Saint-Herblain | 44805 | France |
| Clinique Mutualiste de l'Estuaire | Saint-Nazaire | 44606 | France |
| Centre d'Oncologie Saint-Yves | Vannes | 56000 | France |
| CHBA Vannes | Vannes | 56000 | France |
| Protocol Violation |
|
| Physician Decision |
|
| Death |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| Relapse |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 1 |
| 141 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Standard Cryoprotection | Proposal helmet without mittens and booties cooling helmet | 0 | 139 | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |