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Search / Trial NCT05213936

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Launched by MONTEFIORE MEDICAL CENTER · Jan 17, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking into how hairstyling techniques can improve the effectiveness of scalp cooling for preventing hair loss in patients of color undergoing chemotherapy for breast or lung cancer. Scalp cooling has been shown to help many patients keep their hair during treatment, but previous studies had few participants with skin of color. The researchers are testing methods like braiding or using a special mixture of water and conditioner to reduce hair volume, which may help the cooling cap fit better and work more effectively.

To participate, you need to be over 18 years old, have curly or kinky hair (types 3 or 4), and be starting chemotherapy for early-stage breast or lung cancer. If you join, you'll receive the cooling treatment while undergoing chemotherapy, and the study will follow you for up to six months after treatment to see how well your hair is preserved and to explore any biological markers that might predict success with scalp cooling. This trial aims to ensure that more diverse patients benefit from scalp cooling, improving their overall treatment experience.

Gender

ALL

Eligibility 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

About Montefiore Medical Center

Montefiore Medical Center is a leading academic medical institution located in the Bronx, New York, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a principal sponsor of clinical studies, Montefiore fosters a collaborative environment that connects researchers, healthcare professionals, and patients to explore cutting-edge therapies and improve health outcomes. With a strong emphasis on patient-centered care, the center integrates its extensive clinical expertise with robust research capabilities to address a wide range of medical conditions, contributing significantly to the advancement of medical science and clinical practice.

Locations

Bronx, New York, United States

Bronx, New York, United States

Patients applied

0 patients applied

Trial Officials

Beth McLellan, MD

Principal Investigator

Montefiore Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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