Using scalp cooling and hairstyling to prevent hair loss during chemotherapy for patients of color
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color: A Clinical and Mechanistic Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, doxorubicin |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05213936 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with hair types other than 3 or 4, males, or those with concurrent malignancies may not benefit from this study.
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 performed: Previous studies have shown scalp cooling to be effective in preventing hair loss, but this approach specifically targeting patients of color is novel.
Eligibility criteria
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 this trial is running
The Bronx, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.