Comparative transcriptome profiling provides new insights into mechanisms of androgenetic alopecia progression.
E G Y Chew, B S-Y Ho, S Ramasamy...
https://pubmed.ncbi.nlm.nih.gov/27239811/Actively Recruiting
Led by Montefiore Medical Center · Updated on 2026-07-16
41
Participants Needed
1
Research Sites
21 weeks
Total Duration
Researchers are studying scalp cooling techniques to reduce hair loss caused by chemotherapy in patients with skin of color who have breast cancer or non-small cell lung cancer. The study focuses on improving scalp cooling effectiveness by using hairstyling methods that reduce hair volume, such as braids, twists, or cornrows, and applying a conditioner and water emulsion to the hair. The study also aims to understand persistent hair loss after chemotherapy and investigate molecular markers that may predict scalp cooling success in these patients. Participants are assigned to one of three groups scalp cooling with a hairstyling method to reduce hair bulk, scalp cooling after coating hair with a conditioner and water mixture, or no scalp cooling. Hair preparation will be done according to the participants preferred method before fitting the cooling cap. The study will follow patients during and after chemotherapy treatment to assess hair preservation and adverse events. Participants will be monitored for hair density and hair loss severity up to six months after completing chemotherapy and for persistent hair loss up to 11 months after treatment ends. Researchers will collect data on patient distress related to hair loss at several time points after chemotherapy. The study includes hair follicle sampling for molecular analysis to explore gene expression changes and biomarkers associated with scalp cooling outcomes. Safety assessments and adverse event monitoring are part of the follow-up process.
CONDITIONS
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
B
Beth McLellan, MD
Y
Yana Kost, BA
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Montefiore Medical Center
Lead Sponsor
Paxman Coolers Limited
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Scalp cooling with hairstyle | Scalp cooling with conditioner and water emulsion | No scalp cooling |
|---|---|---|---|
| What it is | Scalp cooling device is used during chemotherapy sessions after preparing hair in a chosen style such as braids, cornrows, or twists. | Scalp cooling device is applied during chemotherapy with hair coated in a conditioner and water emulsion. | No device-based scalp cooling or special pre-treatment is used during chemotherapy. |
| Role in trial | Test arm for assessing the impact of different hair preparation styles with scalp cooling on hair retention in women of color during chemotherapy. | Test arm for evaluating how using conditioner and water emulsion with scalp cooling affects chemotherapy-induced hair loss. | Serves as the control group to compare hair loss outcomes without scalp cooling intervention. |
| Primary use | Aims to reduce the risk and severity of chemotherapy-induced hair loss while accommodating different natural hair types and culturally relevant styles. | Intended to decrease hair loss from chemotherapy by using a conditioner emulsion to improve cooling device fit on natural hair textures. | Represents the standard approach in which no device-based intervention is used to prevent chemotherapy-induced hair loss. |
| How it is given or performed | Participants' hair is styled (e.g., braids, cornrows, twists) before fitting the scalp cooling device, which is worn during each chemotherapy infusion. | Participants apply a conditioner and water emulsion to the hair before placing the cooling cap, which is kept on during each chemotherapy session. | No cooling cap or special scalp treatment is performed; usual hair care practices continue. |
| Evidence status | Device-based scalp cooling has been shown to reduce hair loss in chemotherapy for breast cancer, but evidence on outcomes for women of color and styled hair preparation is still emerging. | Published literature supports scalp cooling to reduce hair loss, but specific results for conditioner and water emulsion preparation in women with type 3 or 4 hair are not widely established. | Those not receiving scalp cooling generally experience prominent or complete hair loss with taxane-based chemotherapy. |
| Important limitations | The benefit of scalp cooling for women with curlier hair types or cultural styles has not been firmly established, and factors such as cap fit and hair density may affect results. | Evidence is limited for this preparation in patients of color; struggles with consistent cap fit, device comfort, and varied hair density and styles may limit effectiveness. | No preventive intervention is given, so almost all patients can expect visible hair loss, with distress and dissatisfaction common. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of chemotherapy treatment (at least 4 cycles)
Participants receive scalp cooling using hairstyling methods or conditioner and water emulsion, or no scalp cooling during taxane-based chemotherapy cycles.
Duration - Up to 11 months after chemotherapy ends
Participants are monitored for hair loss severity, adverse events, and patient distress for up to 11 months after chemotherapy completion.
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Lead Sponsor
Paxman Coolers Limited
Collaborating Sponsor