This clinical trial evaluates whether using hairstyling techniques in patients undergoing scalp cooling can prevent hair loss due to chemotherapy in patients with stage I-III breast or non-small cell lung cancer. Recent studies questioned efficacy of traditional scalp cooling techniques in patients with curly or kinky hair. Patients with this type of hair receiving chemotherapy and scalp cooling using hairstyling techniques to prepare the hair for cooling cap fitting all were able to keep their hair. This trial may help researchers learn more about markers within the hair associated with scalp cooling success and to improve quality of life for patients receiving chemotherapy.
Additional locations may be listed on ClinicalTrials.gov for NCT05213936.
Locations matching your search criteria
United States
New York
Bronx
Montefiore Medical Center-Weiler HospitalStatus: Active
Contact: Beth Mclellan
Phone: 718-920-2680
PRIMARY OBJECTIVE:
I. To assess the efficacy of scalp cooling devices in preventing chemotherapy-induced alopecia in persons of color with hair types 3 or 4 using hair products and hair styles that will enhance contact between the scalp and cooling device.
SECONDARY OBJECTIVE:
I. To investigate whether scalp cooling can decrease the risk of persistent chemotherapy alopecia in skin of color (SOC) patients and impact patient quality of life.
EXPLORATORY OBJECTIVES:
I. To define molecular mechanisms implicated in chemotherapy-induced alopecia (CIA), persistent chemotherapy-induced alopecia (PCIA), and scalp cooling (SC) effect.
II. Identify predictive markers for cooling success through transcriptome profiling on hair follicles before and after chemotherapy in intervention and control groups.
OUTLINE: Patients are self-assigned or randomly assigned to 1 of 3 groups.
GROUP I (SC WITH HAIRSTYLE): Patients undergo scalp cooling with hairstyle (braids, twists, cornrows) before, during, and after chemotherapy infusion on study.
GROUP II (SC WITH CONDITIONER AND WATER): Patients undergo scalp cooling after coating hair with conditioner and water emulsion before, during, and after chemotherapy infusion on study.
GROUP III (CONTROL, NO SCALP COOLING): Patients receive standard of care treatment without any prevention for chemotherapy-induced alopecia.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationMontefiore Medical Center-Weiler Hospital
Principal InvestigatorBeth Mclellan