Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

NCT05213936 | Recruiting FDA Device

• 1 other identifier: 2021-13614
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  26 weeks after completion of chemotherapy, up to ~11 months total

• Severity of persistent chemotherapy-induced alopecia - adverse events

  26 weeks after completion of chemotherapy, up to ~11 months total

• Patient distress after treatment

  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)

Other Outcomes (1)

• Gene expression changes in chemotherapy-induced and persistent chemotherapy-induced alopecia

  26 weeks after completion of chemotherapy

Study Arms (3)

Scalp cooling with hairstyle

EXPERIMENTAL

Scalp cooling with hairstyle (braids, twists, cornrows) to minimize hair volume and increase scalp cooling cap to scalp contact

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

Device: Scalp cooling with conditioner and water emulsion

No Scalp Cooling

NO INTERVENTION

Control with no scalp cooling

Interventions

Scalp cooling with hairstyle DEVICE

Hair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists

Scalp cooling with hairstyle

Scalp cooling with conditioner and water emulsion DEVICE

Hair will be prepared accordingly for the fitting based on which approach the patient prefers: or conditioner and water emulsion to coat the hair.

Scalp Cooling with conditioner and water emulsion

Eligibility Criteria

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

You may qualify if:

• 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
• a. 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Paxman Coolers Limited: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Related Publications (43)

• 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.

  PMID: 2148877 BACKGROUND

• Marks 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.

  PMID: 30806923 BACKGROUND

• Trueb RM. Chemotherapy-induced alopecia. Curr Opin Support Palliat Care. 2010 Dec;4(4):281-4. doi: 10.1097/SPC.0b013e3283409280.

  PMID: 21045702 BACKGROUND

• Gianotti 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.

  PMID: 31259224 BACKGROUND

• Prevezas 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.

  PMID: 19222453 BACKGROUND

• Cersosimo 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.

  PMID: 3005521 BACKGROUND

• Auvinen 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.

  PMID: 20572585 BACKGROUND

• Mols 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.

  PMID: 18560904 BACKGROUND

• Kinahan 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.

  PMID: 22614987 BACKGROUND

• Shin 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.

  PMID: 25081068 BACKGROUND

• Rugo 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.

  PMID: 28196257 BACKGROUND

• Nangia 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.

  PMID: 28196254 BACKGROUND

• Grevelman 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.

  PMID: 15642703 BACKGROUND

• Erecinska 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.

  PMID: 12771566 BACKGROUND

• Friedrichs 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.

  PMID: 25279292 BACKGROUND

• Rice BA, Ver Hoeve ES, DeLuca AN, Esserman LJ, Rugo HS, Melisko ME. Registry study to assess hair loss prevention with the Penguin Cold Cap in breast cancer patients receiving chemotherapy. Breast Cancer Res Treat. 2018 Jan;167(1):117-122. doi: 10.1007/s10549-017-4506-z. Epub 2017 Sep 18.

  PMID: 28921303 BACKGROUND

• Bajpai J, Kagwade S, Chandrasekharan A, Dandekar S, Kanan S, Kembhavi Y, Ghosh J, Banavali SD, Gupta S. "Randomised controlled trial of scalp cooling for the prevention of chemotherapy induced alopecia". Breast. 2020 Feb;49:187-193. doi: 10.1016/j.breast.2019.12.004. Epub 2019 Dec 12.

  PMID: 31865282 BACKGROUND

• Betticher DC, Delmore G, Breitenstein U, Anchisi S, Zimmerli-Schwab B, Muller A, von Moos R, Hugli-Dayer AM, Schefer H, Bodenmann S, Buhler V, Trueb RR. Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment. Support Care Cancer. 2013 Sep;21(9):2565-73. doi: 10.1007/s00520-013-1804-9. Epub 2013 May 2.

  PMID: 23636645 BACKGROUND

• Vasconcelos I, Wiesske A, Schoenegg W. Scalp cooling successfully prevents alopecia in breast cancer patients undergoing anthracycline/taxane-based chemotherapy. Breast. 2018 Aug;40:1-3. doi: 10.1016/j.breast.2018.04.012. Epub 2018 Apr 13.

  PMID: 29660543 BACKGROUND

• Schaffrin-Nabe D, Schmitz I, Josten-Nabe A, von Hehn U, Voigtmann R. The Influence of Various Parameters on the Success of Sensor-Controlled Scalp Cooling in Preventing Chemotherapy-Induced Alopecia. Oncol Res Treat. 2015;38(10):489-95. doi: 10.1159/000440636. Epub 2015 Sep 27.

  PMID: 26451590 BACKGROUND

• Mayo TT, Callender VD. The art of prevention: It's too tight-Loosen up and let your hair down. Int J Womens Dermatol. 2021 Jan 29;7(2):174-179. doi: 10.1016/j.ijwd.2021.01.019. eCollection 2021 Mar.

  PMID: 33937486 BACKGROUND

• Araoye EF, Stearns V, Aguh C. Considerations for the Use of Scalp Cooling Devices in Black Patients. J Clin Oncol. 2020 Oct 20;38(30):3575-3576. doi: 10.1200/JCO.20.02130. Epub 2020 Sep 8. No abstract available.

  PMID: 32897824 BACKGROUND

• Katz A. Scalp Cooling: The Prevention of Chemotherapy-Induced Alopecia . Clin J Oncol Nurs. 2017 Aug 1;21(4):413-415. doi: 10.1188/17.CJON.413-415.

  PMID: 28738048 BACKGROUND

• Komen MM, Smorenburg CH, van den Hurk CJ, Nortier JW. Factors influencing the effectiveness of scalp cooling in the prevention of chemotherapy-induced alopecia. Oncologist. 2013;18(7):885-91. doi: 10.1634/theoncologist.2012-0332. Epub 2013 May 6.

  PMID: 23650021 BACKGROUND

• Teteh D, Ericson M, Monice S, Dawkins-Moultin L, Bahadorani N, Clark P, Mitchell E, Trevino LS, Llanos A, Kittles R, Montgomery S. The Black identity, hair product use, and breast cancer scale. PLoS One. 2019 Dec 4;14(12):e0225305. doi: 10.1371/journal.pone.0225305. eCollection 2019.

  PMID: 31800594 BACKGROUND

• Dilawari A, Gallagher C, Alintah P, Chitalia A, Tiwari S, Paxman R, Adams-Campbell L, Dash C. Does Scalp Cooling Have the Same Efficacy in Black Patients Receiving Chemotherapy for Breast Cancer? Oncologist. 2021 Apr;26(4):292-e548. doi: 10.1002/onco.13690. Epub 2021 Feb 17.

  PMID: 33512741 BACKGROUND

• Janssen FE, Van Leeuwen GM, Van Steenhoven AA. Modelling of temperature and perfusion during scalp cooling. Phys Med Biol. 2005 Sep 7;50(17):4065-73. doi: 10.1088/0031-9155/50/17/010. Epub 2005 Aug 17.

  PMID: 16177530 BACKGROUND

• Nunez-Torres R, Martin M, Garcia-Saenz JA, Rodrigo-Faus M, Del Monte-Millan M, Tejera-Perez H, Pita G, de la Torre-Montero JC, Pinilla K, Herraez B, Peiro-Chova L, Bermejo B, Lluch A, Gonzalez-Neira A. Association Between ABCB1 Genetic Variants and Persistent Chemotherapy-Induced Alopecia in Women With Breast Cancer. JAMA Dermatol. 2020 Sep 1;156(9):987-991. doi: 10.1001/jamadermatol.2020.1867.

  PMID: 32756886 BACKGROUND

• Silva GB, Ciccolini K, Donati A, Hurk CVD. Scalp cooling to prevent chemotherapy-induced alopecia. An Bras Dermatol. 2020 Sep-Oct;95(5):631-637. doi: 10.1016/j.abd.2020.03.005. Epub 2020 Jun 16.

  PMID: 32622629 BACKGROUND

• Freites-Martinez A, Shapiro J, van den Hurk C, Goldfarb S, Jimenez JJ, Rossi AM, Paus R, Lacouture ME. Hair disorders in cancer survivors. J Am Acad Dermatol. 2019 May;80(5):1199-1213. doi: 10.1016/j.jaad.2018.03.056. Epub 2018 Apr 14.

  PMID: 29660423 BACKGROUND

• Kluger N, Jacot W, Frouin E, Rigau V, Poujol S, Dereure O, Guillot B, Romieu G, Bessis D. Permanent scalp alopecia related to breast cancer chemotherapy by sequential fluorouracil/epirubicin/cyclophosphamide (FEC) and docetaxel: a prospective study of 20 patients. Ann Oncol. 2012 Nov;23(11):2879-2884. doi: 10.1093/annonc/mds095. Epub 2012 May 9.

  PMID: 22571858 BACKGROUND

• Slaught C, Roman M, Yashar S, Holland V, Goh C. Permanent Alopecia in Breast Cancer Patients: Role of Taxanes and Endocrine Therapies. Cutis. 2021 Mar;107(3):E17-E22. doi: 10.12788/cutis.0215.

  PMID: 33956617 BACKGROUND

• Fonia A, Cota C, Setterfield JF, Goldberg LJ, Fenton DA, Stefanato CM. Permanent alopecia in patients with breast cancer after taxane chemotherapy and adjuvant hormonal therapy: Clinicopathologic findings in a cohort of 10 patients. J Am Acad Dermatol. 2017 May;76(5):948-957. doi: 10.1016/j.jaad.2016.12.027. Epub 2017 Mar 8.

  PMID: 28284826 BACKGROUND

• Tallon B, Blanchard E, Goldberg LJ. Permanent chemotherapy-induced alopecia: case report and review of the literature. J Am Acad Dermatol. 2010 Aug;63(2):333-6. doi: 10.1016/j.jaad.2009.06.063. Epub 2010 May 14.

  PMID: 20471136 BACKGROUND

• Deutsch A, McLellan BN, Shinoda K. Single-cell transcriptomics in dermatology. JAAD Int. 2020 Oct 6;1(2):182-188. doi: 10.1016/j.jdin.2020.08.001. eCollection 2020 Dec.

  PMID: 34409338 BACKGROUND

• Chew EG, Ho BS, Ramasamy S, Dawson T, Tennakoon C, Liu X, Leong WM, Yang SY, Lim SY, Jaffar H, Hillmer AM, Bigliardi-Qi M, Bigliardi PL. Comparative transcriptome profiling provides new insights into mechanisms of androgenetic alopecia progression. Br J Dermatol. 2017 Jan;176(1):265-269. doi: 10.1111/bjd.14767. Epub 2016 Dec 10. No abstract available.

  PMID: 27239811 BACKGROUND

• Shalbaf M, Alase AA, Berekmeri A, Md Yusof MY, Pistolic J, Goodfield MJ, Edward S, Botchkareva NV, Stacey M, Vital EM, Wittmann M. Plucked hair follicles from patients with chronic discoid lupus erythematosus show a disease-specific molecular signature. Lupus Sci Med. 2019 Jul 14;6(1):e000328. doi: 10.1136/lupus-2019-000328. eCollection 2019.

  PMID: 31413850 BACKGROUND

• Chen PH, Wang CY, Hsia CW, Ho MY, Chen A, Tseng MJ, Wu YF, Chen HM, Huang TH, Liu HT, Shui HA. Impact of taxol on dermal papilla cells--a proteomics and bioinformatics analysis. J Proteomics. 2011 Nov 18;74(12):2760-73. doi: 10.1016/j.jprot.2011.09.019. Epub 2011 Oct 2.

  PMID: 21989266 BACKGROUND

• Haslam IS, Smart E. Chemotherapy-Induced Hair Loss: The Use of Biomarkers for Predicting Alopecic Severity and Treatment Efficacy. Biomark Insights. 2019 Apr 17;14:1177271919842180. doi: 10.1177/1177271919842180. eCollection 2019.

  PMID: 31037027 BACKGROUND

• Gho CG, Braun JE, Tilli CM, Neumann HA, Ramaekers FC. Human follicular stem cells: their presence in plucked hair and follicular cell culture. Br J Dermatol. 2004 May;150(5):860-8. doi: 10.1111/j.1365-2133.2004.05862.x.

  PMID: 15149497 BACKGROUND

• Batyrshina ZS, Yaakov B, Shavit R, Singh A, Tzin V. Comparative transcriptomic and metabolic analysis of wild and domesticated wheat genotypes reveals differences in chemical and physical defense responses against aphids. BMC Plant Biol. 2020 Jan 13;20(1):19. doi: 10.1186/s12870-019-2214-z.

  PMID: 31931716 BACKGROUND

• Bagale K, Paudel S, Cagle H, Sigel E, Kulkarni R. Electronic Cigarette (E-Cigarette) Vapor Exposure Alters the Streptococcus pneumoniae Transcriptome in a Nicotine-Dependent Manner without Affecting Pneumococcal Virulence. Appl Environ Microbiol. 2020 Jan 21;86(3):e02125-19. doi: 10.1128/AEM.02125-19. Print 2020 Jan 21.

  PMID: 31791951 BACKGROUND

• Bray NL, Pimentel H, Melsted P, Pachter L. Near-optimal probabilistic RNA-seq quantification. Nat Biotechnol. 2016 May;34(5):525-7. doi: 10.1038/nbt.3519. Epub 2016 Apr 4.

  PMID: 27043002 BACKGROUND

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Beth McLellan, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth McLellan, MD

CONTACT

(718) 862-8840; bmclella@montefiore.org

Yana Kost, BA

CONTACT

240-383-6896; yana.kost@einsteinmed.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Hair counts using trichoscopy and photographs will be taken at baseline and at the beginning of each chemotherapy cycle, which will be graded by two independent clinicians blinded to the patient group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 28, 2022
• Study Start: October 24, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

US (1)