AlopeciaNCT05213936
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
A study testing Scalp cooling with hairstyle and Scalp cooling with conditioner and water emulsion in people with Alopecia, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate hairstyling techniques aimed at increasing efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia, determine scalp cooling effect on persistent chemotherapy-induced alopecia, and elucidate molecular mechanisms and predictive biomarkers associated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia
- What is being tested?
- Scalp cooling with hairstyle and Scalp cooling with conditioner and water emulsion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2022to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Female
- Hair type 3 (curly) or type 4 (kinky)
- Diagnosis of breast cancer or non-small cell lung cancer (NSCLC) or gynecologic cancer stage I-IV
- Patient will be starting >= 4 cycles of taxane-based chemotherapy treatment for curative intent after enrollment
- Concurrent HER, cisplatin, cyclophosphamide therapies and doxorubicin therapies allowed
- Eastern Cooperative Oncology Group (ECOG) 0-2: fully active, restrictive in physically strenuous activity, ambulatory and capable of self-care
Who cannot join
- Hair type other than 3 or 4
- Male
- Use of hair weave or extensions without plans to remove
- Concurrent malignancy including hematologic malignancies (i.e. leukemia or lymphoma)
- Alopecia Common Terminology Criteria for Adverse Events > grade 1 at baseline
- Past chemotherapy administration if past treatment was <= 10 years ago
Show all 9Show fewer
- History of migraines or cluster headaches, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid dysfunction, cold urticaria, cold agglutinin disease, scalp metastases
- Planned bone marrow ablation chemotherapy or skull irradiation
- Pregnant patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10461
Warner Robinson, DMD, 786-385-7775, warrobinso@montefiore.org
About this study
Official title: Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color: A Clinical and Mechanistic Study
The purpose of this study is to evaluate hairstyling techniques aimed at increasing efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia, determine scalp cooling effect on persistent chemotherapy-induced alopecia, and elucidate molecular mechanisms and predictive biomarkers associated with scalp cooling success in patients with skin of color receiving chemotherapy for breast or non-small cell lung cancer.
This study is being conducted because prior studies have found scalp cooling to be highly effective in preventing hair loss resulting from chemotherapy. However, minority representation was largely limited in completed trials. A recent study found that scalp cooling devices are less efficacious in patients with skin of color, likely because patients with skin of color have hair is predominantly types 3 (curly) and 4 (kinky), which tend to become bulkier when wet and can interfere with scalp cooling cap fitting. The investigators plan to test two techniques aimed at improving scalp cooling efficacy in patients with skin of color through hairstyling methods that minimize hair volume in order to increase cooling cap to scalp contact: 1) cornrows/braids/twists or 2) water/conditioner emulsion on hair. Preliminary data show that breast cancer patients with type 3 or 4 hair receiving taxane chemotherapy and scalp cooling using these techniques to prepare the hair for scalp cooling cap fitting all experienced hair preservation. Additionally, the investigators will also assess persistent chemotherapy-induced alopecia outcomes and incidence by following patients up to 6 months after completing treatment. Finally, specific gene expression changes in taxane-induced chemotherapy-induced alopecia in vitro have been described previously. The investigators will test the hypothesis that scalp cooling reverses such changes in chemotherapy-induced alopecia, assess for biomarkers predictive for scalp cooling success, and investigate persistent chemotherapy-induced alopecia molecular mechanisms using non-invasive transcriptome sequencing on plucked hair follicles.
- Conditions
- Alopecia
- Being tested
- Scalp cooling with hairstyle, Scalp cooling with conditioner and water emulsion
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp cooling with hairstyleDevice
Hair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists
Scalp cooling with conditioner and water emulsionDevice
Hair will be prepared accordingly for the fitting based on which approach the patient prefers: or conditioner and water emulsion to coat the hair.
| Study group | Role | What they receive |
|---|---|---|
| Scalp cooling with hairstyle | Experimental | Scalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact Receives: Device: Scalp cooling with hairstyle |
| Scalp Cooling with conditioner and water emulsion | Experimental | Scalp cooling after coating hair with conditioner and water emulsion to minimize hair volume and increase scalp cooling cap to scalp contact Receives: Device: Scalp cooling with conditioner and water emulsion |
| No Scalp Cooling | No intervention | Control with no scalp cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of chemotherapy-induced alopecia - hair count density
Severity of chemotherapy-induced alopecia, or CIA, as determined by hair count density from trichoscopy will be assessed. Hair count density (hair counts/cm^2) will be summarized by study arm and analyzed using a T-test.
Measured: 4 weeks after completion of chemotherapy, up to ~6 months total
Severity of chemotherapy-induced alopecia - adverse events
Severity of CIA will also be evaluated based on Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading. Results will be summarized by study arm and analyzed Fisher's exact test.
Measured: 4 weeks after the completion of chemotherapy, up to ~6 months total
Secondary outcomes (3)
Severity of persistent chemotherapy-induced alopecia (PCIA) - hair count density
Severity of PCIA, as determined by hair count density from trichoscopy will be assessed. Hair count density (hair counts/cm^2) will be summarized by study arm and analyzed using a T-test.
Measured: 26 weeks after completion of chemotherapy, up to ~11 months total
Severity of persistent chemotherapy-induced alopecia - adverse events
Severity of PCIA will also be evaluated based on Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading. Results will be summarized by study arm and analyzed Fisher's exact test.
Measured: 26 weeks after completion of chemotherapy, up to ~11 months total
Patient distress after treatment
Patient distress after treatment will be assessed by the Chemotherapy-induced Alopecia Distress Scale (CADS) scale. CADS is a 17-item self-report tool used to measure distress related to chemotherapy-induced hair loss across four domains: physical, emotional, activity, and relationship. Participants rate experiences, difficulties, or distress due to hair loss using a 4-point Likert scale ranging from 1 ("Not at all") to 4 ("Very much"), yielding an overall scoring range of 17-68, such that higher CADS scores are associated with higher distress. Results will be summarized by study arm using basic descriptive statistics.
Measured: 4 weeks, 8 weeks, 12 weeks, and 26 weeks after completion of chemotherapy, up to ~11 months total (from the start to completion of chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start24 Oct 2022
- Primary completion18 Sep 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Paxman Coolers Limited
- Responsible party
- Sponsor
- Investigators
- Beth McLellan, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213936
- Sponsor's protocol ID
- 2021-13614
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kiebert GM, Hanneke J, de Haes CJ, Kievit J, van de Velde CJ. Effect of peri-operative chemotherapy on the quality of life of patients with early breast cancer. Eur J Cancer. 1990;26(10):1038-42. doi: 10.1016/0277-5379(90)90046-v.
PubMed 2148877Marks DH, Okhovat JP, Hagigeorges D, Manatis-Lornell AJ, Isakoff SJ, Lacouture ME, Senna MM. The effect of scalp cooling on CIA-related quality of life in breast cancer patients: a systematic review. Breast Cancer Res Treat. 2019 Jun;175(2):267-276. doi: 10.1007/s10549-019-05169-0. Epub 2019 Feb 26.
PubMed 30806923Trueb RM. Chemotherapy-induced alopecia. Curr Opin Support Palliat Care. 2010 Dec;4(4):281-4. doi: 10.1097/SPC.0b013e3283409280.
PubMed 21045702Gianotti E, Razzini G, Bini M, Crivellaro C, Righi A, Darecchio S, Lui S, Basirico ML, Cocconi S, Cagossi K, Ferrari A, Artioli F. Scalp Cooling in Daily Clinical Practice for Breast Cancer Patients Undergoing Curative Chemotherapy: A Multicenter Interventional Study. Asia Pac J Oncol Nurs. 2019 Jul-Sep;6(3):277-282. doi: 10.4103/apjon.apjon_4_19.
PubMed 31259224Prevezas C, Matard B, Pinquier L, Reygagne P. Irreversible and severe alopecia following docetaxel or paclitaxel cytotoxic therapy for breast cancer. Br J Dermatol. 2009 Apr;160(4):883-5. doi: 10.1111/j.1365-2133.2009.09043.x. Epub 2009 Feb 16. No abstract available.
PubMed 19222453Cersosimo RJ, Hong WK. Epirubicin: a review of the pharmacology, clinical activity, and adverse effects of an adriamycin analogue. J Clin Oncol. 1986 Mar;4(3):425-39. doi: 10.1200/JCO.1986.4.3.425.
PubMed 3005521Auvinen PK, Mahonen UA, Soininen KM, Paananen PK, Ranta-Koponen PH, Saavalainen IE, Johansson RT. The effectiveness of a scalp cooling cap in preventing chemotherapy-induced alopecia. Tumori. 2010 Mar-Apr;96(2):271-5. doi: 10.1177/030089161009600214.
PubMed 20572585Mols F, van den Hurk CJ, Vingerhoets AJ, Breed WP. Scalp cooling to prevent chemotherapy-induced hair loss: practical and clinical considerations. Support Care Cancer. 2009 Feb;17(2):181-9. doi: 10.1007/s00520-008-0475-4. Epub 2008 Jun 17.
PubMed 18560904Kinahan KE, Sharp LK, Seidel K, Leisenring W, Didwania A, Lacouture ME, Stovall M, Haryani A, Robison LL, Krull KR. Scarring, disfigurement, and quality of life in long-term survivors of childhood cancer: a report from the Childhood Cancer Survivor study. J Clin Oncol. 2012 Jul 10;30(20):2466-74. doi: 10.1200/JCO.2011.39.3611. Epub 2012 May 21.
PubMed 22614987Shin H, Jo SJ, Kim DH, Kwon O, Myung SK. Efficacy of interventions for prevention of chemotherapy-induced alopecia: a systematic review and meta-analysis. Int J Cancer. 2015 Mar 1;136(5):E442-54. doi: 10.1002/ijc.29115. Epub 2014 Aug 11.
PubMed 25081068Rugo HS, Klein P, Melin SA, Hurvitz SA, Melisko ME, Moore A, Park G, Mitchel J, Bageman E, D'Agostino RB Jr, Ver Hoeve ES, Esserman L, Cigler T. Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer. JAMA. 2017 Feb 14;317(6):606-614. doi: 10.1001/jama.2016.21038.
PubMed 28196257Nangia J, Wang T, Osborne C, Niravath P, Otte K, Papish S, Holmes F, Abraham J, Lacouture M, Courtright J, Paxman R, Rude M, Hilsenbeck S, Osborne CK, Rimawi M. Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial. JAMA. 2017 Feb 14;317(6):596-605. doi: 10.1001/jama.2016.20939.
PubMed 28196254Grevelman EG, Breed WP. Prevention of chemotherapy-induced hair loss by scalp cooling. Ann Oncol. 2005 Mar;16(3):352-8. doi: 10.1093/annonc/mdi088. Epub 2005 Jan 10.
PubMed 15642703Erecinska M, Thoresen M, Silver IA. Effects of hypothermia on energy metabolism in Mammalian central nervous system. J Cereb Blood Flow Metab. 2003 May;23(5):513-30. doi: 10.1097/01.WCB.0000066287.21705.21.
PubMed 12771566Friedrichs K, Carstensen MH. Successful reduction of alopecia induced by anthracycline and taxane containing adjuvant chemotherapy in breast cancer - clinical evaluation of sensor-controlled scalp cooling. Springerplus. 2014 Sep 5;3:500. doi: 10.1186/2193-1801-3-500. eCollection 2014.
PubMed 25279292
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color: A Clinical and Mechanistic Study
- ClinicalTrials.gov ID
- NCT05213936
- Acronym / sponsor ID
- 2021-13614
- Conditions
- Alopecia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Paxman Coolers Limited
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 18 Sep 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Jan 2022 (actual)
- 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.
The purpose of this study is to evaluate hairstyling techniques aimed at increasing efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia, determine scalp cooling effect on persistent chemotherapy-induced alopecia, and elucidate molecular mechanisms and predictive biomarkers associated with scalp cooling success in patients with skin of color receiving chemotherapy for breast or non-small cell lung cancer.
This study is being conducted because prior studies have found scalp cooling to be highly effective in preventing hair loss resulting from chemotherapy. However, minority representation was largely limited in completed trials. A recent study found that scalp cooling devices are less efficacious in patients with skin of color, likely because patients with skin of color have hair is predominantly types 3 (curly) and 4 (kinky), which tend to become bulkier when wet and can interfere with scalp cooling cap fitting. The investigators plan to test two techniques aimed at improving scalp cooling efficacy in patients with skin of color through hairstyling methods that minimize hair volume in order to increase cooling cap to scalp contact: 1) cornrows/braids/twists or 2) water/conditioner emulsion on hair. Preliminary data show that breast cancer patients with type 3 or 4 hair receiving taxane chemotherapy and scalp cooling using these techniques to prepare the hair for scalp cooling cap fitting all experienced hair preservation. Additionally, the investigators will also assess persistent chemotherapy-induced alopecia outcomes and incidence by following patients up to 6 months after completing treatment. Finally, specific gene expression changes in taxane-induced chemotherapy-induced alopecia in vitro have been described previously. The investigators will test the hypothesis that scalp cooling reverses such changes in chemotherapy-induced alopecia, assess for biomarkers predictive for scalp cooling success, and investigate persistent chemotherapy-induced alopecia molecular mechanisms using non-invasive transcriptome sequencing on plucked hair follicles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scalp cooling with hairstyle | Experimental | Device: Scalp cooling with hairstyleScalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact |
| Scalp Cooling with conditioner and water emulsion | Experimental | Device: Scalp cooling with conditioner and water emulsionScalp cooling after coating hair with conditioner and water emulsion to minimize hair volume and increase scalp cooling cap to scalp contact |
| No Scalp Cooling | No intervention | –Control with no scalp cooling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >= 18 years
- Female
- Hair type 3 (curly) or type 4 (kinky)
- Diagnosis of breast cancer or non-small cell lung cancer (NSCLC) or gynecologic cancer stage I-IV
- Patient will be starting >= 4 cycles of taxane-based chemotherapy treatment for curative intent after enrollment
Key exclusion criteria (9 listed)
- Hair type other than 3 or 4
- Male
- Use of hair weave or extensions without plans to remove
- Concurrent malignancy including hematologic malignancies (i.e. leukemia or lymphoma)
- Alopecia Common Terminology Criteria for Adverse Events > grade 1 at baseline
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 |
|---|---|---|
| Scalp cooling with hairstyleHair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists | Device | Scalp cooling with hairstyle |
| Scalp cooling with conditioner and water emulsionHair will be prepared accordingly for the fitting based on which approach the patient prefers: or conditioner and water emulsion to coat the hair. | Device | Scalp Cooling with conditioner and water emulsion |
Primary outcome
Severity of chemotherapy-induced alopecia - hair count density
Time frame: 4 weeks after completion of chemotherapy, up to ~6 months total
Severity of chemotherapy-induced alopecia, or CIA, as determined by hair count density from trichoscopy will be assessed. Hair count density (hair counts/cm^2) will be summarized by study arm and analyzed using a T-test.
Severity of chemotherapy-induced alopecia - adverse events
Time frame: 4 weeks after the completion of chemotherapy, up to ~6 months total
Severity of CIA will also be evaluated based on Common Terminology Criteria for Adverse Events (CTCAE Version 5.0) grading. Results will be summarized by study arm and analyzed Fisher's exact test.
3 secondary outcomes
Severity of persistent chemotherapy-induced alopecia (PCIA) - hair count density
Time frame: 26 weeks after completion of chemotherapy, up to ~11 months total
Severity of persistent chemotherapy-induced alopecia - adverse events
Time frame: 26 weeks after completion of chemotherapy, up to ~11 months total
Patient distress after treatment
Time frame: 4 weeks, 8 weeks, 12 weeks, and 26 weeks after completion of chemotherapy, up to ~11 months total (from the start to completion of chemotherapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 2148877Kiebert GM, Hanneke J, de Haes CJ, Kievit J, van de Velde CJ. Effect of peri-operative chemotherapy on the quality of life of patients with early breast cancer. Eur J Cancer. 1990;26(10):1038-42. doi: 10.1016/0277-5379(90)90046-v.
- Background: PubMed 30806923Marks DH, Okhovat JP, Hagigeorges D, Manatis-Lornell AJ, Isakoff SJ, Lacouture ME, Senna MM. The effect of scalp cooling on CIA-related quality of life in breast cancer patients: a systematic review. Breast Cancer Res Treat. 2019 Jun;175(2):267-276. doi: 10.1007/s10549-019-05169-0. Epub 2019 Feb 26.
- Background: PubMed 21045702Trueb RM. Chemotherapy-induced alopecia. Curr Opin Support Palliat Care. 2010 Dec;4(4):281-4. doi: 10.1097/SPC.0b013e3283409280.
- Background: PubMed 31259224Gianotti E, Razzini G, Bini M, Crivellaro C, Righi A, Darecchio S, Lui S, Basirico ML, Cocconi S, Cagossi K, Ferrari A, Artioli F. Scalp Cooling in Daily Clinical Practice for Breast Cancer Patients Undergoing Curative Chemotherapy: A Multicenter Interventional Study. Asia Pac J Oncol Nurs. 2019 Jul-Sep;6(3):277-282. doi: 10.4103/apjon.apjon_4_19.
- Background: PubMed 19222453Prevezas C, Matard B, Pinquier L, Reygagne P. Irreversible and severe alopecia following docetaxel or paclitaxel cytotoxic therapy for breast cancer. Br J Dermatol. 2009 Apr;160(4):883-5. doi: 10.1111/j.1365-2133.2009.09043.x. Epub 2009 Feb 16. No abstract available.
- Background: PubMed 3005521Cersosimo RJ, Hong WK. Epirubicin: a review of the pharmacology, clinical activity, and adverse effects of an adriamycin analogue. J Clin Oncol. 1986 Mar;4(3):425-39. doi: 10.1200/JCO.1986.4.3.425.
- Background: PubMed 20572585Auvinen PK, Mahonen UA, Soininen KM, Paananen PK, Ranta-Koponen PH, Saavalainen IE, Johansson RT. The effectiveness of a scalp cooling cap in preventing chemotherapy-induced alopecia. Tumori. 2010 Mar-Apr;96(2):271-5. doi: 10.1177/030089161009600214.
- Background: PubMed 18560904Mols F, van den Hurk CJ, Vingerhoets AJ, Breed WP. Scalp cooling to prevent chemotherapy-induced hair loss: practical and clinical considerations. Support Care Cancer. 2009 Feb;17(2):181-9. doi: 10.1007/s00520-008-0475-4. Epub 2008 Jun 17.
- Background: PubMed 22614987Kinahan KE, Sharp LK, Seidel K, Leisenring W, Didwania A, Lacouture ME, Stovall M, Haryani A, Robison LL, Krull KR. Scarring, disfigurement, and quality of life in long-term survivors of childhood cancer: a report from the Childhood Cancer Survivor study. J Clin Oncol. 2012 Jul 10;30(20):2466-74. doi: 10.1200/JCO.2011.39.3611. Epub 2012 May 21.
- Background: PubMed 25081068Shin H, Jo SJ, Kim DH, Kwon O, Myung SK. Efficacy of interventions for prevention of chemotherapy-induced alopecia: a systematic review and meta-analysis. Int J Cancer. 2015 Mar 1;136(5):E442-54. doi: 10.1002/ijc.29115. Epub 2014 Aug 11.
- Background: PubMed 28196257Rugo HS, Klein P, Melin SA, Hurvitz SA, Melisko ME, Moore A, Park G, Mitchel J, Bageman E, D'Agostino RB Jr, Ver Hoeve ES, Esserman L, Cigler T. Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer. JAMA. 2017 Feb 14;317(6):606-614. doi: 10.1001/jama.2016.21038.
- Background: PubMed 28196254Nangia J, Wang T, Osborne C, Niravath P, Otte K, Papish S, Holmes F, Abraham J, Lacouture M, Courtright J, Paxman R, Rude M, Hilsenbeck S, Osborne CK, Rimawi M. Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial. JAMA. 2017 Feb 14;317(6):596-605. doi: 10.1001/jama.2016.20939.
- Individual participant dataSharing planned: Undecided
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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.
Beth McLellan, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalp cooling with hairstyle and Scalp cooling with conditioner and water emulsion in people with Alopecia, run by Montefiore Medical Center at 1 site in United States.
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 9 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth McLellan, MD ((718) 862-8840, bmclella@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of chemotherapy-induced alopecia - hair count density (time frame: 4 weeks after completion of chemotherapy, up to ~6 months total). The study lists 2 primary outcomes in all. 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 NCT05213936, which also lists 43 linked publications.
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 16 Oct 2026.