Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05213936

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

Led by Montefiore Medical Center · Updated on 2025-01-15

30

Participants Needed

1

Research Sites

162 weeks

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

P

Paxman

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating hairstyling methods to improve the effectiveness of scalp cooling in preventing hair loss caused by chemotherapy in patients with skin of color who have breast, non-small cell lung, or gynecologic cancer. The study also aims to understand how scalp cooling affects persistent hair loss after chemotherapy and to explore molecular mechanisms and biomarkers linked to scalp cooling success. This focus arises because scalp cooling has been less effective in patients with type 3 (curly) and type 4 (kinky) hair, common in people with skin of color, due to difficulty fitting cooling caps tightly over bulkier hair. Participants will use one of two hairstyling techniques before scalp cooling: either braids, cornrows, or twists, or a water and conditioner emulsion applied to the hair. These approaches aim to reduce hair volume and improve contact between the cooling cap and the scalp. Scalp cooling devices will then be applied during chemotherapy, which includes taxane-based treatments. The study will follow patients through their chemotherapy cycles and up to six months after treatment ends to assess hair preservation and long-term effects. During the study, researchers will collect hair samples to perform molecular analyses and measure gene expression changes related to chemotherapy-induced hair loss. Participants' hair preservation and distress related to hair loss will be evaluated up to six months after chemotherapy, totaling about 11 months of observation from the start of treatment. The study monitors safety and treatment effects while exploring predictive biomarkers through non-invasive testing methods.

CONDITIONS

Official Title

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >= 18 years
  • Female
  • Hair type 3 (curly) or type 4 (kinky)
  • Diagnosis of breast cancer or non-small cell lung cancer or gynecologic cancer stage I-IV
  • Planning to start >= 4 cycles of taxane-based chemotherapy for curative intent
  • Concurrent HER, cisplatin, cyclophosphamide, and doxorubicin therapies allowed
  • Eastern Cooperative Oncology Group (ECOG) status 0-2 (fully active to ambulatory and capable of self-care)
Not Eligible

You will not qualify if you...

  • Hair type other than 3 or 4
  • Male
  • Use of hair weave or extensions without plans to remove
  • Concurrent malignancy including hematologic malignancies
  • Alopecia Common Terminology Criteria for Adverse Events grade > 1 at baseline
  • Past chemotherapy treatment within the last 10 years
  • History of migraines or cluster headaches, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid dysfunction, cold urticaria, cold agglutinin disease, or scalp metastases
  • Planned bone marrow ablation chemotherapy or skull irradiation
  • Pregnant patient

AI-Screening

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Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10461

Actively Recruiting

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Research Team

B

Beth McLellan, MD

Y

Yana Kost, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Frequently Asked Questions

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