Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Official title

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color: A Clinical and Mechanistic Study

Overview

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.

Interventions

• Device Scalp cooling with hairstyle
  Hair will be prepared accordingly for the cooling cap fitting based on which approach the patient prefers: braids/cornrows/twists
• Device Scalp cooling with conditioner and water emulsion
  Hair will be prepared accordingly for the fitting based on which approach the patient prefers: or conditioner and water emulsion to coat the hair.

Primary outcome measures

• 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 - adverse events [Time frame: 4 weeks after the completion of chemotherapy, up to ~6 months total]

Secondary outcome measures (3)

• 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)]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Montefiore Medical Center — The Bronx

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. PMID 2148877
• 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
• Trueb RM. Chemotherapy-induced alopecia. Curr Opin Support Palliat Care. 2010 Dec;4(4):281-4. doi: 10.1097/SPC.0b013e3283409280. PMID 21045702
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT05213936 · 2021-13614

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗