Image

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

Eligibility

Inclusion Criteria:

  1. Age > 18 years
  2. Hair type 3 (curly) or type 4 (kinky)
  3. Diagnosis of breast or non-small cell lung cancer (NSCLC) stage I-III
  4. Patient will be starting >4 cycles of taxane-based chemotherapy treatment for curative intent after enrollment
    1. Concurrent HER, cisplatin, and cyclophosphamide therapies allowed
  5. 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. Use of hair weave or extensions without plans to remove
  3. Diagnosis of breast cancer or NSCLC stage IV
  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 or administration of anthracyclines (doxorubicin)
  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

Study details
    Alopecia

NCT05213936

Montefiore Medical Center

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.