Breast CancerNCT02863146
Efficacy of the Use of Refrigerant Helmet to Prevent Alopecia in Patients Treated With Eribulin for Breast Cancer
An observational study of Breast Cancer and Metastatic Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial summary
HALACAP-1406 is a prospective single-centre non-interventional study assessing the refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®) in the conditions of use specified in its marketing authorization. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Locally advanced or metastatic breast cancer patients treated with eribulin and whose cancer has progressed after at least 1 chemotherapy regimen for their advanced stage
Who may be able to join
- Female patient who has a locally advanced or metastatic breast cancer
- Indication of Halaven treatment :
- patient pretreated with anthracyclines or taxanes, patient who has received at least 1 chemotherapy regimen for their advanced or metastatic stage
- Patient who has had enough time to have retrieved her hair or whose last chemotherapy regimen didn't induce alopecia.
- Aged ≥ 18 years
- Non-opposition of the patient must have been collected
Who cannot join
- Skin metastasis of the scalp
- Sensitivity to cold, cold agglutinin disease or cryoglobulinemia
- Impossibility to submit at the study procedures due to geographic, social or mental reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Use of a Refrigerant Helmet to Prevent Alopecia in Patients Treated With Eribulin for Locally Advanced or Metastatic Breast Cancer Pretreated With Anthracyclines and Taxanes
HALACAP-1406 is a prospective single-centre non-interventional study assessing the refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®) in the conditions of use specified in its marketing authorization. Eribulin will be used alone for the treatment of the patients having a locally advanced or metastatic breast cancer which have progressed after at least 1 chemotherapy regimen for their advanced stage.
Read the detailed description
A nurse will meet the patient and present the study, then the patient will be invited to participate. If the patient is interested, an information note will be given and the non-opposition of the patient will be collected.
Patients will be registered via a registration form and an inclusion number will be attributed at each patient.
Eribulin will be used within the framework of its marketing authorization, per cycle of 21 days, at day 1 and day 8.
Modalities of refrigerant helmet use will be set according to the habits of the Oscar Lambret center with the following rules :
- Placement of a single-use non-woven hygiene cap on the scalp
- T-15 minutes: placement of the refrigerant helmet
- T0: begin of eribulin infusion (duration: 2-5 minutes)
- T+15 minutes: rinse of the line
- T+30 minutes: withdrawal of the helmet
Efficacy will be evaluated before treatment and at each eribulin cycle.
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Keywords
- locally advanced breast cancer, alopecia, eribulin
- Medical subject headings
- Breast Neoplasms, Alopecia
What is being measured
The primary outcome is the main question the study is designed to answer.
Alopecia grade after 3 cycles of eribulin according to NCI-CTCAE v4.0
Efficacy of the refrigerant helmet : Alopecia grade after 3 cycles of eribulin
Measured: on the day 1 of cycle 4
Secondary outcomes (1)
Adverse events graded according to NCI-CTCAE v4.0
Tolerance of the refrigerant helmet : graduation of adverse events lived by patients
Measured: every 28 days : at day 1 of each cycle during 3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startMay 2015
- Primary completionJul 2017
- Study completionSep 2017
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Laurence VANLEMMENS, MD, Principal investigator, Centre Oscar LambretMonique Blondel, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863146
- Sponsor's protocol ID
- HALACAP-1406
- Status last verified
- Oct 2017
- First submitted
- 15 Feb 2016
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of a Refrigerant Helmet to Prevent Alopecia in Patients Treated With Eribulin for Locally Advanced or Metastatic Breast Cancer Pretreated With Anthracyclines and Taxanes
- ClinicalTrials.gov ID
- NCT02863146
- Acronym / sponsor ID
- HALACAP-1406
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Keywords
- locally advanced breast cancer, alopecia, eribulin
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- May 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HALACAP-1406 is a prospective single-centre non-interventional study assessing the refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®) in the conditions of use specified in its marketing authorization. Eribulin will be used alone for the treatment of the patients having a locally advanced or metastatic breast cancer which have progressed after at least 1 chemotherapy regimen for their advanced stage.
Detailed description
A nurse will meet the patient and present the study, then the patient will be invited to participate. If the patient is interested, an information note will be given and the non-opposition of the patient will be collected.
Patients will be registered via a registration form and an inclusion number will be attributed at each patient.
Eribulin will be used within the framework of its marketing authorization, per cycle of 21 days, at day 1 and day 8.
Modalities of refrigerant helmet use will be set according to the habits of the Oscar Lambret center with the following rules :
- Placement of a single-use non-woven hygiene cap on the scalp
- T-15 minutes: placement of the refrigerant helmet
- T0: begin of eribulin infusion (duration: 2-5 minutes)
- T+15 minutes: rinse of the line
- T+30 minutes: withdrawal of the helmet
Efficacy will be evaluated before treatment and at each eribulin cycle.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced or metastatic breast cancer patients treated with eribulin and whose cancer has progressed after at least 1 chemotherapy regimen for their advanced stage
Key inclusion criteria (6 listed)
- Female patient who has a locally advanced or metastatic breast cancer
- Indication of Halaven treatment :
- patient pretreated with anthracyclines or taxanes, patient who has received at least 1 chemotherapy regimen for their advanced or metastatic stage
- Patient who has had enough time to have retrieved her hair or whose last chemotherapy regimen didn't induce alopecia.
- Aged ≥ 18 years
Key exclusion criteria (3 listed)
- Skin metastasis of the scalp
- Sensitivity to cold, cold agglutinin disease or cryoglobulinemia
- Impossibility to submit at the study procedures due to geographic, social or mental reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alopecia grade after 3 cycles of eribulin according to NCI-CTCAE v4.0
Time frame: on the day 1 of cycle 4
Efficacy of the refrigerant helmet : Alopecia grade after 3 cycles of eribulin
1 secondary outcome
Adverse events graded according to NCI-CTCAE v4.0
Time frame: every 28 days : at day 1 of each cycle during 3 cycles
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Laurence VANLEMMENS, MD principal investigator
Centre Oscar Lambret
Monique Blondel study director
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Metastatic Breast Cancer, run by Centre Oscar Lambret at 1 site 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
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?
Alopecia grade after 3 cycles of eribulin according to NCI-CTCAE v4.0 (time frame: on the day 1 of cycle 4). 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 5 Oct 2017.