AlopeciaPhase 2NCT00515762
Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling
A Phase 2 study testing elasto-gel cap in people with Alopecia and Breast Cancer, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Alopecia, Breast Cancer
- What is being tested?
- elasto-gel cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- May 2007to Jun 2010
- Phase
- Phase 2
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-75
- breast cancer stages II-III
- adjuvant or neoadjuvant chemotherapy with docetaxel regimens (TAC or anthracyclines followed by docetaxel 100 mg/m2 x 4)
Who cannot join
- contraindications for adjuvant docetaxel and or anthracyclines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial of Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling (ELASTO-GEL CAPS)in Breast Cancer Patients
Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.
Read the detailed description
Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. Docetaxel is toxic to skin and skin annexes and can produce nail toxicity and persistent alopecia. Nail toxicity has been successfully prevented by means of hypothermic gloves and slippers (Elasto-gel, Southwest Technologies, Inc, North Kansas City, MO). This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.
- Conditions
- Alopecia, Breast Cancer
- Being tested
- elasto-gel cap
- Keywords
- persistent alopecia, docetaxel, breast cancer
- Medical subject headings
- Alopecia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elasto-gel capDevice
scalp cooling cap
| Study group | Role | What they receive |
|---|---|---|
| 1: scalp cooling | Experimental | scalp cooling Receives: Device: elasto-gel cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients without persistent alopecia
Measured: 2nd year following docetaxel chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlopeciaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Investigators
- miguel martin, MD, PHD, Principal investigator, hospital clinico san carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515762
- Sponsor's protocol ID
- ALOPER-2
- Status last verified
- Jun 2010
- First submitted
- 13 Aug 2007
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martin M, de la Torre-Montero JC, Lopez-Tarruella S, Pinilla K, Casado A, Fernandez S, Jerez Y, Puente J, Palomero I, Gonzalez Del Val R, Del Monte-Millan M, Massarrah T, Vila C, Garcia-Paredes B, Garcia-Saenz JA, Lluch A. Persistent major alopecia following adjuvant docetaxel for breast cancer: incidence, characteristics, and prevention with scalp cooling. Breast Cancer Res Treat. 2018 Oct;171(3):627-634. doi: 10.1007/s10549-018-4855-2. Epub 2018 Jun 19.
PubMed 29923063
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling (ELASTO-GEL CAPS)in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00515762
- Acronym / sponsor ID
- ALOPER-2
- Conditions
- Alopecia, Breast Cancer
- Keywords
- persistent alopecia, docetaxel, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 14 Aug 2007 (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.
Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.
Detailed description
Persistent alopecia following adjuvant docetaxel for breast cancer is a side-effect that has been recently described. Docetaxel is toxic to skin and skin annexes and can produce nail toxicity and persistent alopecia. Nail toxicity has been successfully prevented by means of hypothermic gloves and slippers (Elasto-gel, Southwest Technologies, Inc, North Kansas City, MO). This pilot trial explores the capacity of a cooling cap (Elasto-gel) to prevent persistent alopecia in breast cancer patients treated with adjuvant docetaxel regimens.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: scalp cooling | Experimental | Device: elasto-gel capscalp cooling |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-75
- breast cancer stages II-III
- adjuvant or neoadjuvant chemotherapy with docetaxel regimens (TAC or anthracyclines followed by docetaxel 100 mg/m2 x 4)
Key exclusion criteria (1 listed)
- contraindications for adjuvant docetaxel and or anthracyclines
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 |
|---|---|---|
| elasto-gel capscalp cooling cap | Device | 1: scalp cooling |
Primary outcome
percentage of patients without persistent alopecia
Time frame: 2nd year following docetaxel chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.
- Derived from this study: PubMed 29923063Martin M, de la Torre-Montero JC, Lopez-Tarruella S, Pinilla K, Casado A, Fernandez S, Jerez Y, Puente J, Palomero I, Gonzalez Del Val R, Del Monte-Millan M, Massarrah T, Vila C, Garcia-Paredes B, Garcia-Saenz JA, Lluch A. Persistent major alopecia following adjuvant docetaxel for breast cancer: incidence, characteristics, and prevention with scalp cooling. Breast Cancer Res Treat. 2018 Oct;171(3):627-634. doi: 10.1007/s10549-018-4855-2. Epub 2018 Jun 19.
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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.
miguel martin, MD, PHD principal investigator
hospital clinico san carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing elasto-gel cap in people with Alopecia and Breast Cancer, run by Hospital San Carlos, Madrid at 1 site in Spain.
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 3 inclusion and 1 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 Aug 2011. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percentage of patients without persistent alopecia (time frame: 2nd year following docetaxel chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00515762, which also lists 1 linked publication.
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 Aug 2011; AzTrials last refreshed its copy on 8 Nov 2026.