Breast NeoplasmsBANQUISENCT02283983
Evaluation of Cryoprotection Induced Nail Toxicity Docetaxel Low Cumulative Dose
A study testing mittens and booties and cooling helmet in people with Breast Neoplasms, run by Centre Hospitalier Departemental Vendee at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- mittens and booties and cooling helmet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 10 sitesFrance
- Study dates
- Dec 2014to 25 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Institut de cancérologie de l'Ouest - Angers
Angers, 49933
Centre Hospitalier de Cholet
Cholet, 49300
CHD Vendee
La Roche-sur-Yon, 85925
CH du Mans
Le Mans, 72000
Centre hospitalier Bretagne Sud
Lorient, 56100
Centre Catherine de Sienne
Nantes, 44202
Institut de cancérologie de l'Ouest - Nantes
Saint-Herblain, 44805
Clinique Mutualiste de l'Estuaire
Saint-Nazaire, 44606
Centre d'Oncologie Saint-Yves
Vannes, 56000
CHBA Vannes
Vannes, 56000
About this study
Official title: Evaluation of Cryoprotection of Nail Toxicity Induced by Docetaxel Low Cumulative Dose. Controlled, Randomized, Open, Multicentre Prospective.
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.
Read more
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
- Being tested
- mittens and booties, cooling helmet
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mittens and bootiesOther
cooling helmetOther
| Study group | Role | What they receive |
|---|---|---|
| Standard cryoprotection | Active comparator | Proposal helmet without mittens and booties Receives: Other: cooling helmet |
| Cryoprotection with mittens and booties | Experimental | Standard cryoprotection with mittens and booties Receives: Other: mittens and booties; Other: cooling helmet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks post infusion of docetaxel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2019
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank PRIOU, PH, Study director, CHD Vendee La Roche sur Yon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283983
- Sponsor's protocol ID
- CHD 097-13
- Acronym
- BANQUISE
- Status last verified
- Oct 2024
- First submitted
- 3 Nov 2014
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cryoprotection of Nail Toxicity Induced by Docetaxel Low Cumulative Dose. Controlled, Randomized, Open, Multicentre Prospective.
- ClinicalTrials.gov ID
- NCT02283983
- Acronym / sponsor ID
- BANQUISE / CHD 097-13
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard cryoprotection | Active comparator | Other: cooling helmetProposal helmet without mittens and booties |
| Cryoprotection with mittens and booties | Experimental | Other: mittens and booties, Other: cooling helmetStandard cryoprotection with mittens and booties |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| mittens and booties | Other | Cryoprotection with mittens and booties |
| cooling helmet | Other | Cryoprotection with mittens and booties, Standard cryoprotection |
Primary outcome
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.
Time frame: 8 weeks post infusion of docetaxel
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Frank PRIOU, PH study director
CHD Vendee La Roche sur Yon
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mittens and booties and cooling helmet in people with Breast Neoplasms, run by Centre Hospitalier Departemental Vendee at 10 sites in France.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 8 weeks post infusion of docetaxel). 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 9 Oct 2024.