Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose

Breast Neoplasms Clinical Trial

— BANQUISE  

Official title:

Evaluation of Cryoprotection of Nail Toxicity Induced by Docetaxel Low Cumulative Dose. Controlled, Randomized, Open, Multicentre Prospective.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283983
• Other study ID #: CHD 097-13
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: June 25, 2020

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 25, 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• mittens and booties

• cooling helmet

Locations

Country	Name	City	State
France	Institut de cancérologie de l'Ouest - Angers	Angers
France	Centre Hospitalier de Cholet	Cholet
France	CHD Vendee	La Roche sur Yon
France	CH du Mans	Le Mans
France	Centre hospitalier Bretagne Sud	Lorient
France	Centre Catherine de Sienne	Nantes
France	Institut de cancérologie de l'Ouest - Nantes	Saint-Herblain
France	Clinique Mutualiste de l'Estuaire	Saint-Nazaire
France	Centre d'Oncologie Saint-Yves	Vannes
France	CHBA Vannes	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.		8 weeks post infusion of docetaxel