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Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color

Sponsored by Montefiore Medical Center

About this trial

Last updated a year ago

Study ID

2021-13614

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 months ago

What is this trial 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.

What are the participation requirements?

Yes

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 a. 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

No

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

Locations

Location

Status

Recruiting