Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Status Recruiting

Clinical 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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05213936
Study type	Interventional
Source	Montefiore Medical Center
Contact	Beth McLellan, MD
Phone	(718) 862-8840
Email	bmclella@montefiore.org
Status	Recruiting
Phase	N/A
Start date	October 24, 2022
Completion date	January 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04953416` - Fractional Non-ablative Laser for the Treatment of Hair Loss	N/A
Completed	`NCT01929330` - Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers	Phase 1
Completed	`NCT02919735` - Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN)	Phase 2
Recruiting	`NCT02591823` - Hair Fall in Patients on Low Dose Methotrexate	N/A
Enrolling by invitation	`NCT01651689` - Hair Counts From Vertical and Horizontal Sections of Scalp Biopsy SPecimens in Thai Population With Alopecia	N/A
Completed	`NCT01189279` - Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia	Phase 1
Recruiting	`NCT01111981` - Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia	Phase 4
Terminated	`NCT01385839` - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata	N/A
Active, not recruiting	`NCT03382184` - Fractional Photothermolysis for Hair Follicle Induction	Early Phase 1
Not yet recruiting	`NCT05544448` - In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases	N/A
Completed	`NCT03689452` - The Effect of Platelet Rich Plasma on Non-scarring Alopecia	N/A
Completed	`NCT06409650` - To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia	Phase 2
Recruiting	`NCT00801086` - Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain	Phase 2
Completed	`NCT06095739` - Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002	N/A
Completed	`NCT05587699` - The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A	Phase 1
Completed	`NCT03351322` - ENERGI-F701 for Female Hair Loss Treatment	Phase 2
Terminated	`NCT02935569` - Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy	N/A
Completed	`NCT01590238` - Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)	Phase 3
Not yet recruiting	`NCT01557491` - Hair Regrowth After Bicoronal Incision	N/A
Completed	`NCT00515762` - Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.