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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 41 (estimated) |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, doxorubicin |
| Locations | 1 site (The Bronx, New York) |
| Status | Recruiting |
| Started | October 24, 2022 |
| Main results expected | September 18, 2026 |
| Study ends | February 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT05213936 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
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Montefiore Medical Center
The Bronx, New York, United States Recruiting
Study contacts
- Principal investigator: Beth McLellan, MD — Montefiore Medical Center
- Study coordinator: Beth McLellan, MD
- Email: bmclella@montefiore.org
- Phone: (718) 862-8840
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using scalp cooling to reduce chemotherapy hair loss and protect quality of life for breast cancer patients
This trial will test whether the PAXMAN scalp cooling system helps adults with stage I–III breast cancer keep more hair and feel better during anthracycline- or taxane-based chemotherapy.
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This 24-week trial will try two different herbal capsule formulas plus a hair tonic versus placebos to see if they help adults (18–60) with hair loss and some with gray hair.
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This study is testing whether cryotherapy can help breast cancer patients keep their eyebrows and eyelashes while they undergo chemotherapy.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.