Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose

NCT02283983 | Completed Results

• 1 other identifier: CHD 097-13
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard cryoprotection

ACTIVE COMPARATOR

Proposal helmet without mittens and booties

Other: cooling helmet

Cryoprotection with mittens and booties

EXPERIMENTAL

Standard cryoprotection with mittens and booties

Other: mittens and booties; Other: cooling helmet

Interventions

mittens and booties OTHER

Cryoprotection with mittens and booties

cooling helmet OTHER

Cryoprotection with mittens and booties; Standard cryoprotection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (10)

Institut de cancérologie de l'Ouest - Angers

Angers, 49933, France

Location

Centre Hospitalier de Cholet

Cholet, 49300, France

Location

CHD Vendee

La Roche-sur-Yon, 85925, France

Location

CH du Mans

Le Mans, 72000, France

Location

Centre hospitalier Bretagne Sud

Lorient, 56100, France

Location

Centre Catherine de Sienne

Nantes, 44202, France

Location

Institut de cancérologie de l'Ouest - Nantes

Saint-Herblain, 44805, France

Location

Clinique Mutualiste de l'Estuaire

Saint-Nazaire, 44606, France

Location

Centre d'Oncologie Saint-Yves

Vannes, 56000, France

Location

CHBA Vannes

Vannes, 56000, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Frank PRIOU
• Organization: Centre Hospitalier Départemental Vendée

frank.priou@ght85.fr

0251446161

Study Officials

• Frank PRIOU, PH

  CHD Vendee La Roche sur Yon

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: June 25, 2020
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Locations

FR (10)