Status:
RECRUITING
Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Paxman
Conditions:
Alopecia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate hairstyling techniques aimed at increasing efficacy of scalp cooling in the prevention of chemotherapy-induced alopecia, determine scalp cooling effect on pers...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- Female
- Hair type 3 (curly) or type 4 (kinky)
- Diagnosis of breast cancer or non-small cell lung cancer (NSCLC) or gynecologic cancer stage I-IV
- 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
- Eastern Cooperative Oncology Group (ECOG) 0-2: fully active, restrictive in physically strenuous activity, ambulatory and capable of self-care
Exclusion
- Hair type other than 3 or 4
- Male
- Use of hair weave or extensions without plans to remove
- Concurrent malignancy including hematologic malignancies (i.e. leukemia or lymphoma)
- Alopecia Common Terminology Criteria for Adverse Events \> grade 1 at baseline
- Past chemotherapy administration if past treatment was \<= 10 years ago
- History of migraines or cluster headaches, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid dysfunction, cold urticaria, cold agglutinin disease, scalp metastases
- Planned bone marrow ablation chemotherapy or skull irradiation
- Pregnant patient
Key Trial Info
Start Date :
October 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05213936
Start Date
October 24 2022
End Date
December 1 2025
Last Update
January 15 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Montefiore Medical Center
The Bronx, New York, United States, 10461