Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using scalp cooling and hairstyling to prevent hair loss during chemotherapy for patients of color

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

Run by Montefiore Medical Center · NCT05213936 · Data updated 2026-11-12

This study is testing if combining scalp cooling with special hairstyling can help prevent hair loss during chemotherapy for people of color with curly or kinky hair.

More Alopecia trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment41 (estimated)
SponsorMontefiore Medical Center
Academic / other
Drugs / interventionschemotherapy, cyclophosphamide, doxorubicin
Locations1 site (The Bronx, New York)
StatusRecruiting
StartedOctober 24, 2022
Main results expectedSeptember 18, 2026
Study endsFebruary 2027
Registry record updatedOctober 16, 2026
Trial IDNCT05213936 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are female patients aged 18 and older with hair type 3 or 4, diagnosed with breast cancer or non-small cell lung cancer, and starting at least four cycles of taxane-based chemotherapy.

Probably not a fit

Patients with hair types other than 3 or 4, males, or those with concurrent malignancies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of scalp cooling techniques combined with specific hairstyling methods to prevent chemotherapy-induced hair loss in patients of color. It aims to understand the molecular mechanisms and identify predictive biomarkers associated with the success of scalp cooling in individuals with curly or kinky hair types undergoing chemotherapy for breast or non-small cell lung cancer. The study addresses the underrepresentation of minority populations in previous trials and seeks to improve the efficacy of scalp cooling for these patients.

Why it matters

Potential benefit: If successful, this study could significantly reduce hair loss for patients of color undergoing chemotherapy, improving their quality of life.

How similar studies have gone: Previous studies have shown scalp cooling to be effective in preventing hair loss, but this approach specifically targeting patients of color is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age \>= 18 years
2. Female
3. Hair type 3 (curly) or type 4 (kinky)
4. Diagnosis of breast cancer or non-small cell lung cancer (NSCLC) or gynecologic cancer stage I-IV
5. 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
6. Eastern Cooperative Oncology Group (ECOG) 0-2: fully active, restrictive in physically strenuous activity, ambulatory and capable of self-care

Exclusion Criteria:

1. Hair type other than 3 or 4
2. Male
3. Use of hair weave or extensions without plans to remove
4. Concurrent malignancy including hematologic malignancies (i.e. leukemia or lymphoma)
5. Alopecia Common Terminology Criteria for Adverse Events \> grade 1 at baseline
6. Past chemotherapy administration if past treatment was \<= 10 years ago
7. History of migraines or cluster headaches, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid dysfunction, cold urticaria, cold agglutinin disease, scalp metastases
8. Planned bone marrow ablation chemotherapy or skull irradiation
9. Pregnant patient

Where it's running

  • Montefiore Medical Center
    The Bronx, New York, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.