N/A N=280 Randomized Prevention

Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose

Breast Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT02283983 ↗

Enrolled (actual)

280

Serious AEs

—

Results posted

Oct 2024

Primary outcome: 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. — 26; 49 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: mittens and booties (Other); cooling helmet (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Centre Hospitalier Departemental Vendee
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
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.	26; 49	<0.001 sig

Summary

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.

Eligibility Criteria

Inclusion Criteria

upper age to 18 years
mammary adenocarcinoma nonmetastatic and histologically proven
wait under an adjuvant or neoadjuvant chemotherapy according to the following conventional scheme: 3 cycles of F5-Fluorouracil, epirubicin and cyclophosphamide 100 (500 or 5-Fluorouracil 600 mg / m² J1, Epirubicin 100 mg / m² J1, Cyclophosphamide 500 or 600 mg / m² J1 or 3 cycles of Epiribucin and Cyclophosphamide 100) followed by 3 cycles of docetaxel, 100 mg / m², +/- trastuzumab if Her2+++
Patient with the capacity/faculties to understand a newsletter and sign an informed consent
Patient receiving social coverage
Patient who can be treated and followed in the center for a period of at least one year
WHO scale 0 or 1

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) :
Presence of peripheral neuropathy> grade 1 after the first 3 cycles of 5-Fluorouracil, epirubicin and cyclophosphamide 100.
Presence of a nail or skin toxicity> grade 1 after 3 cycles of 5-Fluorouracil, epirubicin and cyclophosphamide 100.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02283983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.