RECRUITING

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 persistent chemotherapy-induced alopecia, and elucidate molecular mechanisms and predictive biomarkers associated with scalp cooling success in patients with skin of color receiving chemotherapy for breast or non-small cell lung cancer. This study is being conducted because prior studies have found scalp cooling to be highly effective in preventing hair loss resulting from chemotherapy. However, minority representation was largely limited in completed trials. A recent study found that scalp cooling devices are less efficacious in patients with skin of color, likely because patients with skin of color have hair is predominantly types 3 (curly) and 4 (kinky), which tend to become bulkier when wet and can interfere with scalp cooling cap fitting. The investigators plan to test two techniques aimed at improving scalp cooling efficacy in patients with skin of color through hairstyling methods that minimize hair volume in order to increase cooling cap to scalp contact: 1) cornrows/braids/twists or 2) water/conditioner emulsion on hair. Preliminary data show that breast cancer patients with type 3 or 4 hair receiving taxane chemotherapy and scalp cooling using these techniques to prepare the hair for scalp cooling cap fitting all experienced hair preservation. Additionally, the investigators will also assess persistent chemotherapy-induced alopecia outcomes and incidence by following patients up to 6 months after completing treatment. Finally, specific gene expression changes in taxane-induced chemotherapy-induced alopecia in vitro have been described previously. The investigators will test the hypothesis that scalp cooling reverses such changes in chemotherapy-induced alopecia, assess for biomarkers predictive for scalp cooling success, and investigate persistent chemotherapy-induced alopecia molecular mechanisms using non-invasive transcriptome sequencing on plucked hair follicles.

Official Title

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color: A Clinical and Mechanistic Study

Quick Facts

Study Start:2022-10-24
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05213936

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \> 18 years
  2. 2. Hair type 3 (curly) or type 4 (kinky)
  3. 3. Diagnosis of breast or non-small cell lung cancer (NSCLC) stage I-III
  4. 4. Patient will be starting \>4 cycles of taxane-based chemotherapy treatment for curative intent after enrollment
  5. 5. Eastern Cooperative Oncology Group (ECOG) 0-2: fully active, restrictive in physically strenuous activity, ambulatory and capable of self-care
  1. 1. Hair type other than 3 or 4
  2. 2. Use of hair weave or extensions without plans to remove
  3. 3. Diagnosis of breast cancer or NSCLC stage IV
  4. 4. Concurrent malignancy including hematologic malignancies (i.e. leukemia or lymphoma)
  5. 5. Alopecia Common Terminology Criteria for Adverse Events \> grade 1 at baseline
  6. 6. Past chemotherapy administration or administration of anthracyclines (doxorubicin)
  7. 7. History of migraines or cluster headaches, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid dysfunction, cold urticaria, cold agglutinin disease, scalp metastases
  8. 8. Planned bone marrow ablation chemotherapy or skull irradiation

Contacts and Locations

Study Contact

Beth McLellan, MD
CONTACT
(718) 862-8840
bmclella@montefiore.org
Yana Kost, BA
CONTACT
240-383-6896
yana.kost@einsteinmed.org

Principal Investigator

Beth McLellan, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10461
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • Beth McLellan, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-24
Study Completion Date2025-01

Study Record Updates

Study Start Date2022-10-24
Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

  • Alopecia