Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05213936

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Led by Montefiore Medical Center · Updated on 2025-01-15

30

Participants Needed

1

Research Sites

162 weeks

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

P

Paxman

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >= 18 years
  • Female
  • Hair type 3 (curly) or type 4 (kinky)
  • Diagnosis of breast cancer or non-small cell lung cancer or gynecologic cancer stage I-IV
  • Planning to start >= 4 cycles of taxane-based chemotherapy for curative intent
  • Concurrent HER, cisplatin, cyclophosphamide, and doxorubicin therapies allowed
  • Eastern Cooperative Oncology Group (ECOG) status 0-2 (fully active to ambulatory and capable of self-care)
Not Eligible

You will not qualify if you...

  • Hair type other than 3 or 4
  • Male
  • Use of hair weave or extensions without plans to remove
  • Concurrent malignancy including hematologic malignancies
  • Alopecia Common Terminology Criteria for Adverse Events grade > 1 at baseline
  • Past chemotherapy treatment within the last 10 years
  • History of migraines or cluster headaches, anorexia, severe anemia, uncontrolled diabetes, hepatitis, thyroid dysfunction, cold urticaria, cold agglutinin disease, or scalp metastases
  • Planned bone marrow ablation chemotherapy or skull irradiation
  • Pregnant patient

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10461

Actively Recruiting

Loading map...

Research Team

B

Beth McLellan, MD

CONTACT

Y

Yana Kost, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color | DecenTrialz